Compression fixation system

• US 10,588,679 B2
• Filed: 11/02/2015
• Issued: 03/17/2020
• Est. Priority Date: 11/01/2014
• Status: Active Grant

• Current Assignee: Numagenesis, LLC
• Original Assignee: Numagenesis, LLC
• Inventors: Kukla, Robert, Von Amsberg, Marc, Binder, Lawrence
• Primary Examiner(s): Gibson, Eric S
• Application Number:
  US15/521,742
• Publication Number:
  US 20170238983A1
• Time in Patent Office: 1,597 Days
• 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 17/683 comprising bone transfixation elements, e.g. bolt with a distal cooperating element such as a nut
• CPC Class Codes: A61B 17/885 Tools for expanding or compacting bones or discs or cavities therein A61B17/8805, A61B17/7097 take precedence
• CPC Class Codes: A61B 17/8866 for gripping or pushing bones, e.g. approximators joint distractors A61B17/025
• CPC Class Codes: A61B 17/8869 Tensioning devices
• CPC Class Codes: A61B 17/8872 Instruments for putting said fixation devices against or away from the bone A61B17/7074, A61B17/808 take precedence

Abstract

The invention is directed in various aspects to a compression fixation system that includes coupling components and locking assemblies for connecting two or more separate elements in a fixed arrangement. For example, the system is useful for connecting and compressing two or more elements selected from bones and bone fragments. The system includes a substantially linear coupling component, such as, for example, a Kirschner Wire (“K-Wire”) and locking assembly elements that engage with the coupling component in a coaxial orientation. The coupling component includes at least a linear portion and an anchor portion, the anchor portion configured to be fixed within or adjacent to a first one of the elements to be connected and the linear portion configured to be fixed adjacent to a second one of the elements to be connected, where the locking assembly is attached coaxially with and locked against the second element to achieve compression and fixation.

Claims

1. A compression fastener system comprising:

a coupling component having proximal and distal ends, a locking assembly, and an anchor component that is integral with the coupling component at the coupling component'"'"'s distal end, wherein the anchor component is a toggle,

the locking assembly engageable with the coupling component and comprising

at least a first compressible collet, and

at least a first collet compression component;

wherein the locking assembly, when assembled, may be provisionally locked to enable free linear movement along the coupling component.

2. A compression fastener system according to claim 1, the coupling component comprising an elongate wire, the locking assembly also comprising a second collet compression component.

3. A compression fastener system according to claim 2, the first collet compression component comprising a collet seat that receives and is engageable with the compressible collet, and the second collet compression component comprising a compression nut that is engageable with the collet seat and is actuatable between provisionally locked and locked configurations, wherein each of the compressible collet, collet seat and compression nut are generally cylindrical and when assembled share a common center axis, and wherein the collet is engageable and compressible directly with the coupling component.

4. A compression fastener system according to claim 3, wherein engagement between the components is achieved by one of press fitting and threaded engagement between the collet seat and the compression nut.

5. A compression fastener system according to claim 4, wherein the toggle is engageable with the coupling component in a cantilever pivotal arrangement, such that in one configuration, the toggle is pivoted into linear alignment with the coupling component and is nested within a recess therein, and in a second configuration, the toggle is deployed in a generally perpendicular orientation relative to the axis of the coupling component, and wherein the engagement between the locking assembly is by threaded engagement between the collet seat comprising interior threads and a threaded compression nut comprising corresponding threads for engagement with the collet seat.

6. A compression fastener system according to claim 5, wherein at least one of (i) at least a portion of an outer surface of the distal end of the coupling component and (ii) at least a portion of an inner face of the compressible collet comprises a surface feature selected from one or a combination of ridges, grooves, keels, fins, threads, dimples, knurls, and surface texturing, and wherein the surface features of the at least one of the outer surface of the coupling component and the inner face of the compressible collet cooperate with the opposing surface of the assembly when the locking assembly is in a locked configuration to enhance the compressive securement of the locked compression fixture system.

7. A compression fastener system according to claim 6, wherein each of the at least a portion of an outer surface of the distal end of the coupling component and at least a portion of an inner face of the compressible collet comprises a surface feature.

8. A compression fastener system according to claim 7, wherein the compressible collet is selected from (i) unitary slit form that comprises at least one slit selected from a through slit and a partial slit, and (ii) a multi piece form.

9. A compression fastener system according to claim 2, wherein the first collet compression component operates to retain the compressible collet, and wherein the second collet compression component operates in engagement with the first collet compression component in a first configuration to provisionally secure the locking assembly to the coupling component and in a second configuration to fixedly secure the locking assembly into compression locking with the coupling component.

10. A compression fastener system according to claim 9, the first collet compression component comprising a flexible securement ring that is engageable with the compressible collet, and the second collet compression component comprising a locking cap that is engageable with the compressible collet and the securement ring, and actuatable between provisionally locked and locked configurations, wherein each of the compressible collet, securement ring and cap are generally cylindrical, and wherein the compressible collet is engageable and compressible directly with the coupling component, and wherein when the locking assembly and the coupling component are assembled they share a common center axis, and wherein engagement between the components is achieved by press fitting.

11. A compression fastener system according to claim 10, wherein the toggle is engageable with the coupling component in a cantilever pivotal arrangement, such that in one configuration, the toggle is pivoted into linear alignment with the coupling component and is nested within a recess therein, and in a second configuration, the toggle is deployed in a generally perpendicular orientation relative to the axis of the coupling component.

12. A compression fastener system according to claim 11, wherein at least one of (i) at least a portion of an outer surface of the distal end of the coupling component and (ii) at least a portion of an inner face of the compressible collet comprises a surface feature selected from one or a combination of ridges, grooves, keels, fins, threads, dimples, knurls, and surface texturing, and wherein the surface features of the at least one of the outer surface of the coupling component and the inner face of the compressible collet cooperate with the opposing surface of the assembly when the locking assembly is in a locked configuration to enhance the compressive securement of the locked compression fixture system.

13. A compression fastener system according to claim 12, wherein each of the at least a portion of an outer surface of the distal end of the coupling component and at least a portion of an inner face of the compressible collet comprises a surface feature, and wherein the securement ring comprises silicone.

14. A compression fastener system according to claim 13, wherein the compressible collet is selected from (i) a unitary slit form that comprises at least one slit selected from a through slit and a partial slit, and (ii) a multi piece form.

15. A compression fastener system according to claim 9, wherein the locking assembly and the coupling component are preassembled in a provisionally locked configuration, the assembly further comprising an insertion tool that is engageable with the provisionally locked assembly, the insertion tool comprising nesting elongate inner and outer sleeves, the outer sleeve adapted to engage with one of the compressible collet and the first and second compression components and the inner sleeve adapted to engage with the other of the compressible collet and the first and second compression components, the inner and outer sleeves releasably engageable between free and limited degrees of freedom around and along a shared center axis, wherein when the inner and outer sleeves are not engaged, one of the sleeves is actuatable along the axis to direct translation of the assembly distally, and wherein when the inner and outer sleeves are engaged, at least one sleeve is actuatable either around or along the axis to drive fixed engagement between the first and second compression components.

16. A compression fastener system according to claim 15, the first collet compression component comprising a flexible securement ring that is engageable with the compressible collet, and the second collet compression component comprising a locking cap that is engageable with the compressible collet and the securement ring, and actuatable between provisionally locked and locked configurations, wherein each of the compressible collet, securement ring and cap are generally cylindrical, and wherein the compressible collet is engageable and compressible directly with the coupling component, and wherein when the locking assembly and the coupling component are assembled they share a common center axis, and wherein engagement between the components is achieved by press fitting,

wherein the toggle is engageable with the coupling component in a cantilever pivotal arrangement, such that in one configuration, the toggle is pivoted into linear alignment with the coupling component and is nested within a recess therein, and in a second configuration, the toggle is deployed in a generally perpendicular orientation relative to the axis of the coupling component

wherein at least one of (i) at least a portion of an outer surface of the distal end of the coupling component and (ii) at least a portion of an inner face of the compressible collet comprises a surface feature selected from one or a combination of ridges, grooves, keels, fins, threads, dimples, knurls, and surface texturing, and wherein the surface features of the at least one of the outer surface of the coupling component and the inner face of the compressible collet cooperate with the opposing surface of the assembly when the locking assembly is in a locked configuration to enhance the compressive securement of the locked compression fixture system,

wherein each of the at least a portion of an outer surface of the distal end of the coupling component and at least a portion of an inner face of the compressible collet comprises a surface feature, and wherein the securement ring comprises silicone,

wherein the compressible collet is selected from (i) unitary slit form that comprises at least one slit selected from a through slit and a partial slit, and (ii) a multi piece form,

wherein the inner sleeve of the insertion tool engages with the compressible collet and the outer sleeve engages with the locking cap, and wherein upon engagement of the sleeves the outer sleeve is actuated by displacement in a distal direction to lock the locking cap to the securement ring and thereby compress and lock the compressible collet into compressive engagement with the coupling component.

17. A compression fastener system according to claim 15, the first collet compression component comprising collet seat that receives and is engageable with the compressible collet, and the second collet compression component comprising a compression nut that is engageable with the collet seat and is actuatable between provisionally locked and locked configurations, wherein each of the compressible collet, collet seat and compression nut are generally cylindrical and when assembled share a common center axis, and wherein the compressible collet is engageable and compressible directly with the coupling component,

wherein engagement between the components is achieved by one of press fitting and threaded engagement between the collet seat and the compression nut,

wherein the toggle is engageable with the coupling component in a cantilever pivotal arrangement, such that in one configuration, the toggle is pivoted into linear alignment with the coupling component and is nested within a recess therein, and in a second configuration, the toggle is deployed in a generally perpendicular orientation relative to the axis of the coupling component, and wherein the engagement between the locking assembly is by threaded engagement between the collet seat comprising interior threads and a threaded compression nut comprising corresponding threads for engagement with the collet seat,

wherein at least one of (i) at least a portion of an outer surface of the distal end of the coupling component and (ii) at least a portion of an inner face of the compressible collet comprises a surface feature selected from one or a combination of ridges, grooves, keels, fins, threads, dimples, knurls, and surface texturing, and wherein the surface features of the at least one of the outer surface of the coupling component and the inner face of the compressible collet cooperate with the opposing surface of the assembly when the locking assembly is in a locked configuration to enhance the compressive securement of the locked compression fixture system,

wherein each of the at least a portion of an outer surface of the distal end of the coupling component and at least a portion of an inner face of the compressible collet comprises a surface feature,

wherein the compressible collet is selected from (i) unitary slit form that comprises at least one slit selected from a through slit and a partial slit, and (ii) a multi piece form, and wherein the inner sleeve of the insertion tool engages with the nut and the outer sleeve engages with the collet seat, and wherein upon engagement of the sleeves the inner sleeve is actuated by rotation around the shared axis to drive further engagement of the engaged threads of the collet seat and the nut in a distal direction to lock the nut to the collet seat and thereby compress and lock the compressible collet into compressive engagement with the coupling component.

18. A compression fastener system according to claim 1, wherein the compression component comprises a securement ring that operates to retain the compressible collet in a first configuration to provisionally secure the locking assembly to the coupling component and in a second configuration to fixedly secure the locking assembly into compression locking with the coupling component, wherein each of the compressible collet and the securement ring are generally cylindrical, and wherein the compressible collet is engageable and compressible directly with the coupling component, and wherein when the locking assembly and the coupling component are assembled they share a common center axis, and wherein engagement between the components is achieved by press fitting, wherein, the securement ring comprises a contractile material that is responsive to application of an activator selected from one or more of heat, electrical, chemical and mechanical compressive force such that in a pre activated form, the ring is either or both pliable and has a circumferential dimension that is greater than the receiving recess of the compressible collet, and in the activated form the ring is contracted so that it becomes more rigid and contracts to assume a smaller circumferential diameter such that it fits within and compresses against the compressible collet thereby locking the assembly to the coupling component.

19. A compression fastener system comprising:

a coupling component having proximal and distal ends and an elongate axis,

a toggle anchor affixed to the distal end of the coupling component, the toggle anchor being pivotal around an axis that is perpendicular to the elongate axis of the coupling component, and

a locking assembly that is engageable with the coupling component in a co-axial orientation around the elongate axis of the coupling component, the locking assembly comprising a compressible collet and a collet compression component.

20. A compression fastener system according to claim 19, wherein the coupling component is selected from a wire and a bone pin.

21. A compression fastener system according to claim 19, wherein the collet compression component is selected from (i) a locking cap that is engagable with the compressible collet, and (ii) a seat for retaining the compressible collet, and a compression nut that is engagable with the seat.

22. A compression fastener system according to claim 21, wherein the collet compression component is a locking cap that is engagable with the compressible collet and further comprises a flexible securement ring that is engageable circumferentially on an outer surface of the compressible collet, the locking cap being further engageable with the securement ring.

23. A compression fastener system according to claim 22, wherein the coupling component is a wire that comprises flexible metal, and wherein the compressible collet comprises on its outer surface a circumferential recess for retaining the flexible securement ring.

24. A method for achieving compression fixation of a plurality of bone elements, comprising:

inserting an elongate coupling component having distal and proximal ends into a through hole in each of the bone elements, the bone elements arranged for fixation along a generally linear path from a proximal position to a distal position,

actuating an anchor at the distal end of the coupling component into engagement with a distal face of the most distally positioned bone element,

sequentially engaging each of a locking assembly, and tensioning and insertion tools into engagement with the coupling component, the tensioning tool engaged fixedly with the proximal end of the coupling component and also engaged loosely with a more distal portion of the coupling component;

each of the locking assembly and the insertion tool engaged along an axis that is shared with the coupling component, the insertion tool positioned between a more distal engagement position of the tensioning tool and the most proximally positioned fragment of the aligned bone fragments, and the locking assembly positioned between the insertion tool and the most proximally positioned fragment of the aligned bone fragments,

actuating the tensioning tool to displace the coupling component in a proximal direction thereby exerting distally directed pressure on the insertion tool whereby distally directed pressure is also exerted on the locking assembly to direct the locking assembly into compressive contact with the most proximally positioned fragment, and

actuating the insertion tool to engage the locking assembly into a locked configuration.