Login| Sign Up| Help| Contact|

Patent Searching and Data


Title:
INTRAMEDULLARY NAIL
Document Type and Number:
WIPO Patent Application WO/2019/217184
Kind Code:
A1
Abstract:
Apparatus and methods for an intramedullary nail. Preferably, the nail includes three components, including two longitudinal sections that are slidable relative to one another, so as to not restrain any growth of the bone. A third threaded member is rotatably coupled to one of the sliding pieces, and the other of the sliding pieces includes a threaded end. The nail is threadably coupled to a bone. Other embodiments include a bone fastener that can be coupled to different bones or bone fragments, maintaining the two different bone pieces rotationally stable relative to one another, but permitting growth between the two bones.

Inventors:
GIORDANO MICHAEL (US)
MUIR NICHOLAS (US)
CHRISTNER JOEL (US)
VEGA LUIS (US)
Application Number:
PCT/US2019/030332
Publication Date:
November 14, 2019
Filing Date:
May 02, 2019
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
ORTHOPEDIATRICS CORP (US)
International Classes:
A61B17/72; A61B17/17; A61B17/56; A61B17/58; A61B17/78
Foreign References:
US8961516B22015-02-24
US4016874A1977-04-12
US6648889B22003-11-18
US7455673B22008-11-25
US20080200987A12008-08-21
Attorney, Agent or Firm:
DANILUCK, John, V. (US)
Download PDF:
Claims:
WHAT IS CLAIMED IS:

1. A device implantable in the intramedullary canal of a bone, comprising: a first elongated sliding member having a first distal end and a first proximal end and a first cross sectional exterior shape therebetween, the first distal end including threads adapted and configured to engage an interior of a bone;

a second elongated sliding member having a second distal end and a second proximal end and a second cross sectional interior shape therebetween, said second interior shape being adapted and configured to slidingly receive within it the first exterior shape, wherein the first cross sectional shape and the second cross sectional shape are selected to limit rotation of said first sliding member relative to said second sliding member to less than about one complete revolution when said first exterior shape is received within the second interior shape; and

a third member having a third distal end and a third proximal end, said third member being rotatable about the second proximal end, the third distal end including threads adapted and configured to engage a bone.

2. The device of claim 1 wherein said third member is rotatable about the second proximal end by more than one complete revolution.

3. The device of claim 1 wherein said first cross sectional shape is not circular and said second cross sectional shape is not circular.

4. The device of claim 3 wherein said first cross sectional shape has a maximum dimension, said second cross sectional shape has a minimum dimension, and the maximum dimension is greater than the minimum dimension.

5. The device of claim 1 wherein the third proximal end has a shape adapted and configured to mate with a first tool for rotation of said third member.

6. The device of claim 5 wherein said third member includes an aperture receiving therein the second proximal end, the second proximal end having a shape adapted and configured to mate with a second tool for rotation of said first sliding member.

7. The device of claim 5 wherein the shape of the third proximal end is a shape around the periphery of said third member.

8. The device of claim 1 wherein the third proximal end includes a receptacle for receiving therein the second proximal end, the second proximal end being externally accessible.

9. The device of claim 1 wherein the third member is restrained from movement along the length of said second elongated member by obstruction between said third member and the second proximal end.

10. The device of claim 1 which further comprises a separable retention member located between the second proximal end and said third member, said retention member restraining axial movement of said third member relative to said second member but permitting rotational movement of said third member relative to said second member.

11 . The device of claim 10 wherein said second member includes a groove, said third member includes a groove, and the two grooves face each other and form a channel for receiving therein said retention member.

12. The device of claim 1 wherein the interlocking of said first member to said second member defines a central axis, and the second proximal end has a second through aperture that is non-parallel to the axis and said third member has a third aperture that is non-parallel to the axis, and said third member can be rotated about said second member so that the second through aperture can be aligned with the third aperture.

13. The device of claim 12 which further comprises a fourth member adapted and configured to be received within the aligned second and third apertures.

14. The device of claim 13 wherein said fourth member is an elongated pin.

15. The device of claim 12 wherein the second proximal end of said second member includes an internal bore along the central axis and which further comprises an expandable locking body insertable within the internal bore and a threaded member receivable within said locking body, wherein the threaded insertion of said fastener within said locking body expands said locking body into a tight fit within the internal bore.

16. The device of claim 12 wherein the second proximal end of said second member includes an internal bore along the central axis and which further comprises a locking body insertable within the internal bore and having a flexible section and a threaded member receivable within said locking body, wherein the threaded insertion of said fastener within said locking body bends the flexible portion into the aligned second and third apertures.

17. A device implantable in the intramedullary canal of a bone, comprising: a first elongated sliding member having a first distal end and a first proximal end and a first cross sectional shape therebetween, the first distal end including threads adapted and configured to engage an interior of a bone;

a second elongated sliding member having a second distal end and a second proximal end and a second cross sectional shape therebetween, said second cross sectional shape being adapted and configured to slidingly interlock with the first cross sectional shape, wherein said first sliding member and said second sliding member are prevented from relative rotation when slidingly interlocked; and

a separate third member having a third distal end and a third proximal end, said third member being lockable to the second proximal end, the third distal end including threads adapted and configured to engage a bone.

18. The device of claim 17 wherein the third proximal end has a shape adapted and configured to mate with a first tool for rotation of said third member.

19. The device of claim 18 wherein said third member includes an aperture receiving therein the second proximal end, the second proximal end having a shape adapted and configured to mate with a second tool for rotation of said first sliding member.

20. The device of claim 18 wherein the shape of the third proximal end is a shape on the proximal face of said third member.

21 . The device of claim 17 wherein the second proximal end has a shape adapted and configured to mate with a tool for rotation of said first sliding member.

22. The device of claim 17 wherein at least one of said first sliding member or said second sliding member includes a shoulder that limits the length of the relative sliding of said first sliding member relative to said second sliding member.

23. The device of claim 17 wherein said third member is rotatable about the second proximal end by more than one complete revolution.

24. The device of claim 17 wherein the first cross sectional shape is complementary to the second cross sectional shape.

25. The device of claim 17 wherein the first member and the second member slide along a longitudinal axis, and the first cross sectional shape is substantially the same as the second cross sectional shape rotated 180 degrees about the longitudinal axis.

26. The device of claim 17 which further comprises a separable retention member located between the second proximal end and said third member, said retention member restraining axial movement of said third member relative to said second member but permitting rotational movement of said third member relative to said second member.

27. The device of claim 26 wherein said third member can rotate relative to said second member by more than 360 degrees.

28. The device of claim 26 wherein said retention member is a wire.

29. The device of claim 17 wherein the interlocking of said first member to said second member defines a central axis, and the second proximal end has a second through aperture that is non-parallel to the axis and said third member has a third aperture that is non-parallel to the axis, and said third member can be rotated about said second member so that the second through aperture can be aligned with the third aperture.

30. The device of claim 29 which further comprises a fourth member adapted and configured to be received within the aligned second and third apertures.

31 . The device of claim 30 wherein said fourth member is a bone screw.

32. The device of claim 29 wherein the second through aperture is an elongated slot, and the third through aperture is an elongated slot.

33. The device of claim 29 wherein said second member includes an internal bore along the central axis and which further comprises a locking assembly receivable within the internal bore, said locking assembly including a pawl receivable within the aligned second and third apertures and adapted and configured to discourage relative rotation of said third member and said second member.

34. The device of claim 29 wherein the second proximal end of said second member includes an internal bore along the central axis and which further comprises a locking assembly insertable within the internal bore, said locking assembly including a flexible portion that can be moved into the aligned second and third apertures.

35. A device for securement to a bone, comprising:

a first elongated sliding member having a first distal end and a first proximal end and a first cross sectional shape therebetween, the first distal end including threads adapted and configured to engage a bone;

a second elongated sliding member having a second distal end and a second proximal end and a second cross sectional shape therebetween, said second proximal end including a tool coupling feature adapted and configured to receive an applied torque, said second cross sectional shape being adapted and configured to slidingly couple with the first cross sectional shape, said first cross sectional shape and said second cross sectional shape being adapted and configured to transmit torque between said first sliding member and said second sliding member;

a third member having a third distal end and a third proximal end, said third member being captured on the second proximal end and being rotatable about the second proximal end, the third distal end including threads adapted and configured to engage a bone.

36 The device of claim 35 wherein said first cross sectional shape is not circular and said second cross sectional shape is not circular.

37. The device of claim 36 wherein said first cross sectional shape has a maximum dimension, said second cross sectional shape has a minimum dimension, and the maximum dimension is greater than the minimum dimension.

38. The device of claim 35 wherein the third proximal end has a shape adapted and configured to mate with a first tool for rotation of said third member.

39. The device of claim 38 wherein said third member includes an aperture receiving therein the second proximal end, the second proximal end having a shape adapted and configured to mate with a second tool for rotation of said first sliding member.

40. The device of claim 35 wherein the second proximal end has a shape adapted and configured to mate with a tool for rotation of said second sliding member.

41 . The device of claim 35 wherein the third proximal end includes a receptacle for receiving therein the second proximal end, the second proximal end being externally accessible.

42. The device of claim 35 wherein at least one of said first sliding member or said second sliding member includes a shoulder that limits the length of the relative sliding of said first sliding member relative to said second sliding member.

43. The device of claim 35 wherein the third member is restrained from movement along the length of said second elongated member by obstruction between said third member and the second proximal end.

44. A kit for orthopedic surgery, comprising:

a bone implant, including:

a first elongated sliding member having a first distal end and a first proximal end and a first cross sectional shape therebetween, the first distal end including threads adapted and configured to engage a bone;

a second elongated sliding member having a second distal end and a second proximal end and a second cross sectional shape therebetween, said second proximal end including a first tool coupling feature, said second cross sectional shape being adapted and configured to slidingly couple with the first cross sectional shape; and a third member having a third distal end and a third proximal end, said third member being rotatable about the second proximal end, the third distal end including threads adapted and configured to engage a bone, the third proximal end including an aperture that extends completely through said third member, the second proximal end being receivable within the aperture; and

a tool for implanting said bone implant, including:

an outer sleeve having an inner passage;

an inner sleeve having a central channel and a fourth proximal end with an outer diameter receivable within the inner passage, and a fourth distal end having a free shape that is larger than the inner passage, said fourth distal end being elastically compressible to a compressed shape that is receivable within the inner passage, the fourth distal end being adapted and configured to grip the periphery of said third member when compressed; and

a rod having a distal end with a second tool coupling feature adapted and configured to couple with the first tool coupling feature and transmit a torque from said rod to said second sliding member, said rod being received within the central channel.

45. The kit of claim 44 wherein said inner sleeve is longitudinally slidable relative to said outer sleeve and said inner sleeve is substantially unable to rotate relative to said outer sleeve.

46. The kit of claim 44 wherein the fourth distal end a radially extending lip adapted and configured to surround a portion of the periphery of said third member.

47. The kit of claim 44 wherein the third proximal end includes a dovetail groove and the fourth distal end includes a dovetail adapted and configured to be slidingly inserted into the dovetail groove.

48. A tool for manipulating two bone implants, including:

an outer sleeve a first distal end and having an inner passage;

an inner sleeve movable within the inner passage and having a central channel and a second proximal end with an outer diameter slidable within the inner passage, and a second distal end having a free shape that is larger than the inner passage, said second distal end being elastically compressible to a compressed shape that is receivable within the inner passage, the second distal end being adapted and

configured to grip an end of one bone implant when compressed and to not grip the end of the one bone implant when in the free shape;

a rod having a distal end with a tool coupling feature adapted and configured to couple with the other bone implant and transmit a torque from said rod to the other bone implant, said rod being rotatable within the central channel; and

a spring biasing said inner sleeve in a direction relative to outer sleeve to move the second distal end toward the inner passage.

49. The tool of claim 48 wherein said outer sleeve include a first distal end with a first handle, said inner sleeve includes a second handle slidable within said outer sleeve, and compression of the first handle toward the second handle reduces the force exerted by said spring on said rod.

50. The tool of claim 48 wherein the fourth distal end includes a feature that reduces the hoop stiffness of said inner sleeve.

51 . The tool of claim 50 wherein the stiffness reducing feature is a slit in the sidewall.

52. The tool of claim 50 wherein the stiffness reducing feature is a localizing thinning of the sidewall.

53. The tool of claim 48 wherein said outer sleeve includes an outer cylindrical midsection, said inner sleeve includes an inner cylindrical midsection, and second proximal end and the second distal end are adapted and configured to slidably capture said outer sleeve on said inner sleeve.

Description:
INTRAMEDULLARY NAIL

CROSS REFERENCE TO RELATED APPLICATION

This application claims the benefit of priority to U.S. Provisional Patent

Application Serial No. 62/668,767, filed May 8, 2018, incorporated herein by reference.

FIELD OF THE INVENTION

Various embodiments of the present invention pertain to apparatus and methods fixation of two bones or bone fragments, and for the internal support of a bone, including bones having active growth plates.

SUMMARY OF THE INVENTION

Various embodiments of the present invention pertain to variable length bone implants useful for attaching together multiple bones or multiple bone fragments, and permitting the attached bones to separate from one another, but resisting any relative rotation of one attached bone or bone fragment relative to the other attached bone or bone fragment.

Various embodiments of the present invention include multi-component bone implant assemblies, with two of the components able to longitudinally slide apart from one another, with a third component preferably being freely rotatable about the end of one of the sliding components. In still further embodiments, the relative rotation can be prevented with use of a locking member or locking assembly.

In still further embodiments, there is a multi-component bone implant assembly, with one end of the assembly being threaded, and the other end of the assembly being threaded. The two threaded ends can be displaced relative to one another along a guided pathway. In some embodiments, this guided pathway is provided by an intermediate sliding member.

Yet another embodiment of the present invention pertains to a three component bone implant assembly. One of the components includes a threaded end, and the other end is received within a separate threaded member that is captured to the end of the threaded component, but able to freely rotate relative to the threaded component. This rotatable component includes threads adapted and configured for attachment to a bone. The first component can be threaded into one part of a bone or bone fragment, the rotatable component can be threaded into another bone or bone component, and then a third component comprising a rotational lock can be used to prevent relative rotation of the two components after they have been appropriately coupled to the bone material.

Yet another embodiment of the present invention pertains to a tool for implanting a bone implant. In one embodiment the tool includes an outer cylinder that is captured on the midsection of an inner cylindrical component. The inner and outer cylindrical components are spring loaded relative to one another. Preferably, the two cylindrical components are further slidable relative to one another.

In yet another embodiment, there is a tool assembly for manipulating a bone implant. The assembly includes inner and outer members that are slidable relative to one another. When the distal end of the innermost member slides into the distal end of the outermost member, one or more end effectors at the distal end of the innermost member changes from a first geometry in which the end effector does not grip a portion of the bone implant, to a second state in which the end effector provides a positive grip onto the bone implant. In some embodiments, the first state is a free-state, and the second state is a compressed state. Still further, it is preferable that the end effector be repeatedly and elastically movable between the two states.

It will be appreciated that the various apparatus and methods described in this summary section, as well as elsewhere in this application, can be expressed as a large number of different combinations and subcombinations. All such useful, novel, and inventive combinations and subcombinations are contemplated herein, it being recognized that the explicit expression of each of these combinations is unnecessary.

BRIEF DESCRIPTION OF THE DRAWINGS

Some of the figures shown herein may include dimensions. Further, some of the figures shown herein may have been created from scaled drawings or from photographs that are scalable. It is understood that such dimensions, or the relative scaling within a figure, are by way of example, and not to be construed as limiting.

FIGS. 1A and 1 B are side perspective line drawings of intramedullary nail assemblies for a femur and tibia, respectively.

FIGS. 2 include various views of the apparatus of FIG. 1 A showing: (A) top view; (B) orthogonal side elevational view; (C) orthogonal bottom view; (D) cross sectional view; (E) distal end view; and (F) proximal end view.

FIGS. 3 include various views of a portion of the apparatus of FIG. 1 A, showing: (A) top view; (B) orthogonal side elevational view; (C) orthogonal bottom view; (E) distal end view; and (F) proximal end view.

FIGS. 4 include various views of a portion of the apparatus of FIG. 1 A, showing: (A) orthogonal top view; (B) orthogonal side elevational view; (C) orthogonal bottom view; (E) distal end view; and (F) proximal end view.

FIGS. 5 include various views of a portion of the apparatus of FIG. 1 A showing: (A) top plan view; (B) right side elevational view; (C) view orthogonal to (A); (D) view orthogonal to (C); and (E) top, right side perspective view.

FIGS. 6 include various views of portions of the apparatus of FIG. 1A, including: (A) partly exploded side elevational view; (B) side, distal perspective view, exploded; (C) cross sectional view of a portion of the apparatus of FIG. 2B; and (D) CAD surface representation of a cross sectional view of a portion of the apparatus of FIG. 2C.

FIGS. 7 show portions of the apparatus of FIGS. 1 A or 1 B, including: (A) side elevational view; and (B) top plan view, as assembled.

FIGS. 8 show portions of the apparatus of FIGS. 1 A or 1 B, with: (A) an end elevational view; and (B) a side elevational view.

FIGS. 9 show alternate portions of the apparatus of FIGS. 1 A or 1 B, including:

(A) a top plan view; (B) orthogonal side elevational view; and (C) orthogonal bottom plan view.

FIGS. 10 show alternate portions of the apparatus of FIGS. 1A or 1 B, including: (A) a top plan view; (B) orthogonal side elevational view; (C) orthogonal bottom plan view; and (D) perspective exploded view of a portion of an alternate apparatus. FIGS. 1 1 show various views of the apparatus of FIG. 1 B including: (A) top view;

(B) orthogonal side elevational view; (C) orthogonal bottom view; (D) cross sectional view; (E) distal end view; and (F) proximal end view.

FIGS. 12 show various views of a portion of the apparatus of FIG. 1A, including: (A) top view; (B) side elevational view; and (C) bottom view.

FIGS. 13 show portions of the apparatus of FIG. 1 B, including: (A) a top plan view; (B) a side elevational view orthogonal to (A); and (C) a top, side perspective view.

FIGS. 14 show various views of a portion of the apparatus of FIG. 1 B including: (A) side elevational, partly assembled view; (B) partly assembled side elevational view;

(C) partly side elevational view; (D) cross sectional view taken through line 14D-14D of FIG. of (A); and (E) CAD surface representation showing a cross section of the assembly of FIG. 1 1 C

FIGS. 15 show various stages of a tool installing the apparatus of either FIG. 1A or FIG. 1 B, including: (A) tool and implant disengaged; (B) tool engaged with cross sectional shape; (C) tool engaged with proximal body; and (D) tool engaged with fully compressed implant.

FIG. 16 is cross sectional representation of a long bone having implanted within it the apparatus of FIGS. 1 A or 1 B.

FIGS. 17 show various alternatives of the implantation shown in FIG. 16, including: (A) alternative proximal implantation; (B) alternative proximal implantation and (C) alternative distal implantation.

FIG. 18 is a partial top view looking down of a portion of the apparatus of FIG.

3C.

FIG. 19 is a partial view of the apparatus of FIG. 3B as viewed from the opposite side of FIG. 3B.

FIG. 20 is a partial view of the apparatus of FIG. 3A as viewed from the opposite side of FIG. 3A.

FIG. 21 A and 21 B are side perspective line drawings of intramedullary nail assemblies for a femur and tibia, respectively.

FIG. 22A is a cross sectional, perspective view of a portion of the proximal end of the apparatus of FIG. 21A.

FIG. 22B shows the apparatus of FIG. 22A with a locking assembly partially inserted. FIG. 23 is a cross sectional, perspective view of a portion of the proximal end of the assembly of FIG. 21 B.

FIG. 24A and FIG. 24B are side perspective line drawings showing the outer surfaces of tool assemblies for installing intramedullary nail assemblies for a femur or tibia, respectively.

FIG. 25A is a side elevational perspective representation of the apparatus of FIG.

24A.

FIG. 25B is a perspective representation of the apparatus of FIG. 25A.

FIG. 26A is a side elevational cutaway view of the apparatus of FIG. 24A.

FIG. 26B is a perspective representation of the apparatus as shown in FIG. 26A.

FIG. 26C is an enlarged view of a portion of the apparatus of FIG. 26A.

FIG. 27A is a side perspective CAD surface representation of a bone screw according to another embodiment of the present invention.

FIG. 27B is a cross sectional representation of the apparatus of FIG. 27A.

FIG. 28A is a side elevational CAD surface representation of the apparatus of FIG. 21 A.

FIG. 28B is an orthogonal view of the apparatus of FIG. 28A.

FIG. 28C is an orthogonal view of the apparatus of FIG. 28B.

FIG. 28D is a top plan view of the apparatus of FIG. 27A.

FIG. 28E is a bottom plan view of the apparatus of FIG. 27A.

FIG. 29A, FIG. 29B, and FIG. 29C present exemplary cross sectional

representations of the guided portions of member X30 and X40 according to various embodiments of the present invention.

FIG. 30A is a side elevational close up representation of a portion of the apparatus of FIG. 23.

FIG. 30B shows the apparatus of FIG. 30A coupled to an insertion tool according to one embodiment of the present invention.

FIG. 30C shows the apparatus of FIG. 30B from the opposite side.

FIG. 30D is a close up representation of a portion of the apparatus of FIG. 22A, and showing it coupled to an insertion tool according to another embodiment of the present invention.

FIG. 30D is a side elevational view of an intermediate cylindrical member of a tool assembly according to one embodiment of the present invention. FIG. 30E is a side elevational view of the apparatus of FIG. 30D as inserted in an outer cylindrical member.

FIG. 30F shows the apparatus of FIG. 30E coupled to distal end of an intramedullary nail assembly, according to one embodiment of the present invention.

ELEMENT NUMBERING

The following is a list of element numbers and at least one noun used to describe that element. It is understood that none of the embodiments disclosed herein are limited to these nouns, and these element numbers can further include other words that would be understood by a person of ordinary skill reading this disclosure in its entirety

DETAILED DESCRIPTION OF ONE OR MORE EMBODIMENTS

For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated device, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates. At least one embodiment of the present invention will be described and shown, and this application may show and/or describe other embodiments of the present invention, and further permits the reasonable and logical inference of still other embodiments as would be understood by persons of ordinary skill in the art.

It is understood that any reference to“the invention” is a reference to an embodiment of a family of inventions, with no single embodiment including an apparatus, process, or composition that should be included in all embodiments, unless otherwise stated. Further, although there may be discussion with regards to

“advantages” provided by some embodiments of the present invention, it is understood that yet other embodiments may not include those same advantages, or may include yet different advantages. Any advantages described herein are not to be construed as limiting to any of the claims. The usage of words indicating preference, such as “various embodiments” or“preferably,” refers to features and aspects that are present in at least one embodiment, but which are optional for some embodiments, it therefore being understood that use of the word“preferably” implies the term“optional.”.

The use of an N-series prefix for an element number (NXX.XX) refers to an element that is the same as the non-prefixed element (XX.XX), except as shown and described. As an example, an element 1020.1 would be the same as element 20.1 , except for those different features of element 1020.1 shown and described. Further, common elements and common features of related elements may be drawn in the same manner in different figures, and/or use the same symbology in different figures. As such, it is not necessary to describe the features of 1020.1 and 20.1 that are the same, since these common features are apparent to a person of ordinary skill in the related field of technology. Further, it is understood that some features 1020.1 and 20.1 may be backward compatible, such that a feature of a later discussed embodiment (NXX.XX) may include features compatible with other various embodiments that were discussed earlier (MXX.XX), as would be understood by those of ordinary skill in the art. This description convention also applies to the use of prime (‘), double prime (“), and triple prime (‘”) suffixed element numbers. Therefore, it is not necessary to describe the features of 20.1 , 20. T, 20.1”, and 20. T” that are the same, since these common features are apparent to persons of ordinary skill in the related field of technology.

Although various specific quantities (spatial dimensions, temperatures, pressures, times, force, resistance, current, voltage, concentrations, wavelengths, frequencies, heat transfer coefficients, dimensionless parameters, etc.) may be stated herein, such specific quantities are presented as examples only, and further, unless otherwise explicitly noted, are approximate values, and should be considered as if the word“about” prefaced each quantity. Further, with discussion pertaining to a specific composition of matter, that description is by example only, and does not limit the applicability of other species of that composition, nor does it limit the applicability of other compositions unrelated to the cited composition.

This document may use different words to describe the same element number, or to refer to an element number in a specific family of features (NXX.XX). It is understood that such multiple, different words are not intended to provide a redefinition of any language herein. It is understood that such words demonstrate that the particular feature can be considered in various linguistical ways, such ways not necessarily being additive or exclusive.

FIGS. 1A and 1 B show side perspective views of implantable intramedullary nail assemblies 20 and 120, respectively. Assembly 20 is adapted and configured for implantation in a femur. Nail assembly 120 is adapted and configured for implantation into a tibia. However, it is understood that various other embodiments of the present invention pertain to implantation in any type of bone. Intramedullary nail assemblies according to various embodiments of the present invention are configured such that one end of the assembly is secured to bone on one proximal side of a proximal growth plate, and the other side of the nail is configured to be attached to the same bone on the distal side of the opposite distal growth plate of that same bone plate.

In the case of pediatric patients, as the growth plate continues to lengthen the bone, the distal and proximal attachment ends of the assembly will slide apart to accommodate that growth without attempting to restrain that growth. However, the sliding portions of the nail assembly are adapted and configured to be slidingly coupled such that each of the sliding sections (X30 and X40) are constrained to guide one another along a longitudinal axis. Preferably, one of the members X30 or X40 defines an open, longitudinal inner open shape that accommodates within it the external shape of the other of the sliding members X30 or X40. It is understood that the cross sectional shapes can be of any configuration that permits such sliding, yet at the same time limit the relative rotation of one member X30 or X40 relative to the other member X30 or X40. In still further embodiments, the cross sectional shapes are chosen to prevent rotation of one member relative to the other member.

Preferably, the outer shape of one of the sliding members is constant along the length of the member, and likewise the internal shape of the other member is constant along the direction of sliding. Various embodiments of the present invention

contemplate any manner of cross sectional shapes. In some embodiments, one of the sliding members has a male shape, and the other of the sliding members has a female shape. In some embodiments, the cross sectional shapes are complementary to one another, whereas in yet other embodiments the shapes have non-complementary cross sections.

In still further embodiments, the nail assembly is constructed of mating pieces that interlock such that even though sliding movement is permitted, the cross sectional shape of the assembly minimizes bending and rotation of the bone, so as to maintain the integrity of any fracture sites, and to maintain the linear relationship of the bone established by the surgeon. As can be seen in FIG. 1 A and 1 B, each assembly 20 and 120 includes a central length 26 or 126, respectively, in which two sliding members maintain interlocking engagement with each other. Although assembly 20 has been described as being used with a femur and assembly 120 with a tibia, it is understood that the devices are not so limited, and the features shown for any of the assemblies herein can be used with other assemblies and with other bones.

FIGS. 1 A and 1 B show that each nail assembly comprises three parts, including a first sliding member (30 or 130) that is interlocked with a second sliding member (40 or 140). The proximal end of the second sliding member is captured by a proximal body (50 or 150) that is able to rotate relative to the second sliding member, but is not able to move axially or laterally relative to the sliding member. It can also be seen that each of the assemblies includes a threaded distalmost end, and also threads on the proximal end, on the rotating body.

FIGS. 2 show various views of nail assembly 20. The nail assembly 20 shown in FIGS.2 is fully compressed or nested, whereas the same assembly in FIG. 1 A is shown partially expanded. When the two sliding members 30 and 40 are slidingly interlocked to one another, the assembly defines a central axis 22 that is generally aligned with both threads 37 and 57. However, it is understood that in various other embodiments of the present invention it is not necessary to have a feature identifiable as a central axis, nor is it necessary to have the threaded ends in alignment with each other.

Referring to FIG. 2B, it can be seen that the distal sliding member 30 includes an abutting shoulder 33 that abuts against the distalmost end 41 a of second sliding member 40. This abutment establishes the minimum length of assembly 20. The proximal most end 31 b of sliding member 30 can be received within a receptacle or pocket 43 located on the proximal end of sliding member 40, although the present invention also contemplates those embodiments in which the proximal 31 b of sliding member 30 is not received within any type of receptacle or pocket. It can also be seen that when the two sliding members are interlocked, that the transverse through holes 35 and 45 are generally aligned in the same orientation. It can also be seen that rotating body 50 is shown in a position such that through hole 55 aligns with through hole 45. As will be discussed later, these transverse holes 35, 45, and 55 are adapted and configured to receive therein a mechanism or device for coupling the ends of the assembly 20 within the bone so as to prevent rotation of the implanted assembly.

Although what has been shown to describe are transverse holes 35, 45 and 55 that are generally perpendicular to the assembly central axis 22, yet other embodiments of the present invention contemplate different features. For example, each of the apertures 35, 45, 55, can be elongated slots that permit reception therethrough of a pin or a fastener that is placed at a non-perpendicular angle relative to central access 22. Still further, what has been shown and described are apertures 35 and 45 that have the same angular orientation, such as the orientation shown in Fig. 2B in which both apertures 35 and 45 are both shown perpendicular to central axis 22, and further both parallel to one another. Yet other embodiments contemplate any angular orientation of apertures or slots 35 and 45.

Referring to FIG. 2D, an interlocked view of members 30 and 40 is shown. In one embodiment, the members have shapes that interlock with each other and permit a torque to be applied from one sliding member to the other sliding member without the two members losing interlock. In addition, the interlocking shape permits a bending moment applied to one sliding member to the pass through to the other sliding member. Further, the shape is adapted and configured such that the two sliding members cannot pull apart from each other without permanent deformation of one or both sliding members. In one preferred embodiment, each sliding member 30 and 40 has a corresponding cross sectional shape 32b or 42b that is identical to the other shape, but rotated 180 degrees. It has been found that such a construction is a benefit for the tooling, inspection, and similar strength profiles of these components.

FIGS. 29A, 29B, and 29C show still further versions of the cross section of slidingly engaged members X40 and X30. Generally, it is understood that the cross sectional shapes need not be interlocked as shown in FIG. 2D, and can instead be a pairing of cross sectional shapes that permits each sliding member to guide itself with the other sliding member, and further permit substantially unimpeded sliding movement. Preferably, the shapes are selected such that applying a torque to one of the sliding members will result in preferably no more than a slight amount of rotation, and thereafter transmit the torque from that driving sliding member to the other driven sliding member. In some embodiments, this transmission of torques from one sliding member to another can be accomplished generally if the exterior of the inner shape and the interior of the outer shape are not circular.

With regards to the application of torque from one member to another, it is understood that during implantation or removal of the implant, the torque applied from one sliding member to another sliding member (between engaged members X30 and X40, but before member X50 is locked onto X40) is the same as the torque being applied by the surgeon using a tool (such as X80, described later) to either tighten or loosen the threads at the distalmost end of the implant. However, after the implant is installed, the torque is applied between the distalmost threads (on the distal sliding member) relative to the proximal threads (on the third, proximal-most member, after it is locked onto X40). This torque applied through the three component assembly (X30,

X40, and X50) is a result of a relative torque applied to the distal and proximal bones or bone fragments.

Cross sectional shapes that are envisaged include combinations of elliptical, oblong, square, rectangular, triangular, and still further polygons, as examples. As shown in FIG. 29B, an elliptical cross sectional shape for member X30-2 can be slidingly accommodated within a square inner cross sectional shape of the other sliding member X40-2. FIG. 29A depicts an elliptical within elliptical cross sectional assembly. Further, it can be seen that sliding member X40 can include a lengthwise slot, or otherwise be a shape that does not completely enclose the inner sliding member X30-1 . FIG. 29C shows another example of a square cross sectional shape within a square cross sectional shape. Still further, the cross sectional shape of one sliding member can be female, and the cross sectional shape of the other sliding member can be male, and it is understood that the distal sliding member (X20) can include either the male or female component, and the proximal sliding member X40 can include the other of the male or female shape.

FIGS. 2E and 2F show end views of nail assembly 20. It can be seen that the projected planform shape of the proximal end of rotating member 50 includes features adapted and configured for implantation. On one lateral side of the shape 58b is a substantially flat but rounded edge with which the flattening lessens the possibility of interference with any nearby biological structures. The opposite side of the shape 58b includes a pair of rounded cutouts that are adapted and configured to mate with an installation tool, as will be shown and discussed later. Although a proximal end with distinctive features adapted and configured for application of a torque have been shown and described, it is understood that such torqueing features can be of any shape.

Referring to FIG. 2F, it can be seen that the proximal end 41 b of sliding member 40 is received within a through aperture 58a within rotating head 50. It can also be seen that proximal end 41 b further includes an inner tool coupling shape 48b that is adapted and configured to mate with a tool, and by which the tool can apply a torque to both sliding members 40 and 30. In one embodiment, the shape 48b represents material removed from the proximal end 41 b, and further having a shape similar (and preferably identical) to the cross sectional shapes shown in FIGS. 2D. However, in yet other embodiments the inner coupling shape 48b for the tool can be of any shape that reliably transmits torque, and may also be a shape that extends as a projection, rather than a receptacle. However, yet other embodiments of the sliding members shown herein are not constrained to the use of interlocking engagement profiles, and further contemplate those embodiments in which the two sliding members comprise a tube and a rod that provide bending stiffness without interlocking.

Referring to FIGS. 3, it can be seen that distal sliding member 30 includes a sliding length 32c that extends from proximal end 31 b to a shoulder 33. Preferably, the interlocking shape 32b extends along this entire length. However, the present invention further contemplates sliding members 30, 40 in which the engaging features are located on only a portion of the length. Referring to FIG. 3A, it can be seen that in some embodiments a sliding body (either distal 30 or proximal 40) can include one or more features 34 for manipulation of the sliding body, either during implantation or during manufacturing. As examples, sliding body 30 includes a hole 34b preferably located near proximal end 31 b, through which a tool such as a hook or wire can be inserted for pulling the sliding body. As another example sliding body 30 also includes a groove 34a, preferably located near distal end 31 a, and extending at least part way around the outer surface of body 30. A tool (not shown) having an end with a complementary shaped located feature can locate the end in the grove to allow for rotational or axial manipulation of the sliding body. These manipulation features are shown enlarged in FIGS. 18, 19, and 20.

Referring to FIGS. 4, it can likewise be seen that proximal sliding member 40 preferably includes an interlocking shape 42b that extends along the entire length from distal end 41 a to the proximal end 41 b (and through the proximal face 41 b indicated in FIG. 4F). In some embodiments, the distal end 41 b includes a pocket or receptacle 43 that is externally adapted and configured to receive within it the proximal end 31 b of sliding member 30. However, the present invention also contemplates those

embodiments in which the proximal end of member 30 is not received within the pocket 43. Referring to FIGS. 4A and 4C, it can be seen that the proximal end 41 B includes a groove or coupling channel 49a located between a pair of larger diameter lands or skirts 49b.

FIGS. 5 show various views of the rotating body 50. As best seen in FIGS. 5C and 5E, it can be seen that the rotating body includes a feed aperture 59b that is externally accessible from the side of body 50. This feed aperture 59b is in internal alignment with a coupling channel 59a located on the inner diameter of aperture 58a. Preferably, the aperture 59b and channel 59a are both located on the proximal side of through aperture 55, although various embodiments of the present invention

contemplate other locations as well.

FIGS. 6 show the assembly of a rotating body 50 onto a sliding member 40. Referring to FIG. 6B, in some embodiments, the rotating body 50 is slid first over distal end 41 a, and freely slides to the proximal end 41 b until the travel stop 56 on the interior of aperture 58a contacts and interferes with the travel stop 46 adjacent to the first land 49b. The contact of travel stops 46 and 56 limits the axial movement of body 50 on body 40 in one direction. Further, these travel stops 46 and 56 are adapted and configured such that the resultant maximum axial movement of body 50 on body 40 results in alignment of coupling channels 49a and 59a. When body 50 is so placed, and referring to FIG. 6C, it can be seen that a coupling member 60 can be inserted into feed aperture 59b. Because of the flexibility of the feature 60, pushing it into the combined coupling channels results in the feature 60 wrapping around proximal end 41 b, and within the volume defined by channels 59a and 49a. As can be seen in FIG. 6D, the placement of coupling feature 60 into this channel prevents axial motion of body 50 relative to body 40 in either axial direction, with the features 49a, 59a, and 60 resulting in physical interference or obstruction that prevents separation. However, it is also contemplated in other embodiments that the placement of the coupling feature 60 will result in restraining only a single direction of axial movement. FIG. 7 shows a coupling feature 60 according to one embodiment. Preferably, coupling feature 60 is a thin, flexible wire that readily deforms into the shape of the channel as shown in FIG. 6C.

Although what has been shown and described is the use of a flexible pin within a coupling channel, the channel being defined by two adjacent members, yet other embodiments of the present invention contemplate other methods of restraining the axial and lateral movement of rotating body 50 relative to slide of body 40. As one example, yet other embodiments contemplate the features similar in function to cotter pins, locking clips, e-clips, and the like, in which the pin or clip extends through a meeting feature on body 40, with the pin or clip preventing axial separation.

FIGS. 8, 9, and 10 show an alternative construction for the elongated distal sliding member 30. Referring to FIGS. 9, it can be seen that in another embodiment a body 30’ has a sliding engagement length 32’ that extends entirely from one end 31 a’ to the other end 31 b’. Along this entire length the cross sectional shape is substantially the same as that shown in FIG. 3F. Body 30’ further includes a pair of through holes 32b’ located at the proximal end 31 a’.

Referring to FIG. 10, it can be seen that a second separate component 31 a’ includes some of the features shown for sliding member 30 that were omitted for sliding member 30’. Separable distal end 31 a’ includes threads 37’ that are substantially the same as threads 37 previously described. Further, a transverse aperture 35’ extends completely through the body of device 31 a’. Body 31 a’ further includes a short section having a cross sectional shape 32b’ that is slidingly received by the distal end of component 30’. A complete distal sliding body in one embodiment is fabricated by slidingly engaging separable components 30’ and 31 a’ and aligning holes 32d’ with the corresponding through holes 32d2’. When so assembled, pins 62 can be placed through the aligned holes so as to lock component 31 a’ to component 30’.

Figs. 1 1 , 12, 13, and 14 show various views an implantable intramedullary nail assembly 120 according to another embodiment of the present invention. As previously stated, the use of a Ί” prefix indicates a feature, aspect, or function that is similar to the previously described non-prefixed feature, aspect, or function, except as shown in described.

Figs. 1 1 show an intramedullary nail assembly 120 adapted and configured for implantation into a tibia. As can be seen in Fig. 1 1 F there is a proximal rotating member 150 has a different tool coupling shape 158b, in comparison to tool coupling shape 58b. The tool coupling shape 158b of device 122 includes a plurality of features that generally extend toward the proximal direction from the top face of rotating body 150. These features are further shown in Figs. 13. This is in contrast to the proximal-most end 41 b shown in Fig. 2F, in which the cross-sectional shape 42b is expressed within a larger solid diameter, and in which the coupling cross-sectional shape 32b has been removed

Referring to Fig. 13C it can be seen that a pair of proximally extending facial features extend proximally on either side of a central groove. This groove in the face of body 150 can been seen in the side view of Fig. 13B, and further can be seen as an approximate Y-groove in Fig. 13A. Although a specific arrangement of coupling features arranged on the body proximal face, it is understood that the present invention contemplates other shapes and features, such as screwdriver-type features such as blade or Philips-type heads, internal hex pockets or external upstanding hex-drive features, and the like.

Rotating body 150 further includes an aperture 158a into which the proximal end 141 b extends. It can further been seen that the cross-sectional shape 142b extends to the proximal-most face of apparatus 120, from which it is accessible a tool having a smaller coupling shape.

It can be further seen in comparing the tool coupling shapes 58b and158b that the shape 58b of the proximal-most head of body 50 includes laterally extending or overhanging shoulders that are adapted and configured to come in to contact with an external surface of the bone. Therefore, when body 50 is threadably engaged with the bone, the portion of bone between the threads 57 and the underside, bone-facing side of the overhanging shoulders will place a corresponding section of the bone into compression. In contrast, in referring to Fig. 13C, it can be seen that the threaded coupling of body 150 into the bone may not result in compression of the bone between the threads and the top bone surface. Instead, referring to Fig. 13B, it can be seen that the top region of cap 150 has substantially the same outer diameter as the major diameter of the largest of the threads 157. Therefore, engaging a body 150 in a bone is less likely to place the bone surrounding the hole in compression. Further, the lack of overhanging shoulders or similar features also permits the top surface of the rotating body to be placed flush with the surface of the bone, or sub-flush and below the surface of the bone.

Figs. 14 depict the assembly of the rotating member 150 onto the proximal sliding member 140. Briefly comparing the cross-sectional views Fig. 14E and Fig. 6D, it can be seen that rotating body 150 does not include the same structure for a travel stop 56, nor does sliding body 140 include structure comparable to travel stop 46.

Therefore, body 150 can be assembled onto body 140 from the proximal end 141 b, sliding in a distal direction. However, head 150 does include an internal shoulder 156 that will limit the distal direction sliding movement of head 150. Therefore, as shown in Figs. 14B and 14C, the rotating body 150 is moved distally on to the proximal end 141 b, with the shoulder 156 abutting the top surface of end 141 b and thereby providing axial alignment of channels 149a and 149b. As depicted in Fig. 14C, a retention member 160 is used to capture rotating member 150 onto the proximal end 141 b, such that rotating member 150 is free to rotate about the central axis 122, but yet is not able to move axially. Fig. 14D shows the finished installation of a retention member such as a wire 160 within the coupling channel.

Although what has been shown and described is the use of a flexible pin within a coupling channel, the channel being defined by two adjacent members, yet other embodiments of the present invention contemplate other methods of restraining the axial and lateral movement of rotating body 150 relative to slide of body 140. As one example, yet other embodiments contemplate the features similar in function to cotter pins, locking clips, e-clips, and the like, in which the pin or clip extends through a meeting feature on body 40, with the pin or clip preventing axial separation.

Fig. 15 show the use of a tool 80 that is adapted and configured for usage with an intramedullary nail such as nails assemblies 20 or 120 described herein. Tool 80 includes a handle 82 that supports an inner shaft 83, and supports a slidably mounted shaft 84. Slide 84 includes its own handle 82b that can be used both to position slide 84 along inner shaft 83, and also to rotate slide 84 independently of shaft 83. The distal end of shaft 83 includes a tool 86a having a cross-sectional shape that adapted and configured to apply a torque to a shape such as coupling shape 48b or 148b (Figs. 2 or 1 1 , respectively). Slide 84 includes a proximal end having a second tool 86b located on the distal end that has a shape adapted and configured for applying a torque to a rotational body (50, 150) by way of the outer coupling shape (58b, 158b), as best seen in Figs. 2F or 13C, respectively.

Fig. 15B shows tool 80 having been moved toward a rotatable body 50, 150, with inner tool end 86a being received within a tool coupling feature 48b or 148b. In this position, the surgeon can rotate handle 82a and thereby rotate the interlocked sliding members (30, 40) or (130, 140). With nail 20, 120 implanted in an intramedullary canal, the threads 37,137 will engage the bone.

After the distal end of assembly 20, 120 is suitably engaged with bone, the surgeon moves slide 84 into a position in which the outer tool 86b is coupled to features 58B or 158B, as seen in Fig. 15C. The surgeon can then use handle 82a to maintain the position of the interlocked sliding members, while simultaneously using handle 82b to rotate slide 84 to engage threads 57, 157 into the distal portion of the bone.

Figs. 16 and 17 show various aspects of a nail assembly 20 installed within an intramedullary canal. It can be seen that the distal end of assembly 20 is threadably engaged at a distal anchoring location 1 1 a. A fastener or alignment pin 24 extends through transfer hole 35, with the ends of the fastener being anchored in bone. The nail assembly 20 extends through the intramedullary canal 12 to the proximal anchoring location 1 1 b, where the threads 57 are engaged with bone 10. Another fastener or pin 24 extends through the aligned holes 47 and 57, with a portion of the fastener or pin being coupled to bone 10. Figs. 17A and 17B show various alternative features for anchoring the proximal sliding member and proximal rotating body to the bone, including a pin 24, passing through slots 47 and 57 that permit a non-perpendicular orientation of fastener 24 relative to central access 22. It is understood that the transverse holes in the sliding members permit the use of any type of device for anchoring the nail assembly to the bone to prevent rotation or other movement of the nail assembly relative to the bone.

FIGS. 21 A and 21 B show side perspective views of implantable intramedullary nail assemblies 320 and 420, respectively. Assembly 320 is adapted and configured for implantation in a femur. Nail assembly 420 is adapted and configured for implantation into a tibia. However, it is understood that various other embodiments of the present invention pertain to implantation in any type of bone. Intramedullary nail assemblies according to various embodiments of the present invention are configured such that one end of the assembly is secured to bone on one proximal side of a proximal growth plate, and the other side of the nail is configured to be attached to the same bone on the distal side of the opposite distal growth plate of that same bone plate. It is further understood that in yet other embodiments the assemblies X20 described herein can be attached to adjacent bones or bone fragments, and still further to bones or bone fragments separated by a third bone or bone fragment, and further not necessarily be located relative to a growth plate.

In the case of pediatric patients, as the growth plate continues to lengthen the bone, the distal and proximal attachment ends of the assembly will slide apart to accommodate that growth without attempting to restrain that growth. However, the sliding portions of the nail assembly are adapted and configured to be slidingly coupled such that each of the sliding sections (X30 and X40) are constrained to guide one another along a longitudinal axis. Preferably, one of the members X30 or X40 defines an open, longitudinal inner open shape that accommodates within it the external shape of the other of the sliding members X30 or X40. It is understood that the cross sectional shapes can be of any configuration that permits such sliding, yet at the same time limit the relative rotation of one member X30 or X40 relative to the other member X30 or X40. Preferably, the outer shape of one of the sliding members is constant along the length of the member, and likewise the internal shape of the other member is constant along the direction of sliding.

Various embodiments of the present invention contemplate any manner of cross sectional shapes. In still further embodiments, the nail assembly is constructed of mating pieces that interlock such that even though sliding movement is permitted, the cross sectional shape of the assembly minimizes bending and rotation of the bone, so as to maintain the integrity of any fracture sites, and to maintain the linear relationship of the bone established by the surgeon. As can be seen in FIG. 21 A and 21 B, each assembly 320 and 420 includes a central length 326 or 426, respectively, in which two sliding members maintain guiding engagement and/or interlocking engagement with each other. Although assembly 320 has been described as being used with a femur and assembly 420 with a tibia, it is understood that the devices are not so limited, and the features shown for any of the assemblies herein can be used with other assemblies and with other bones.

FIGS. 21 A and 21 B show that each nail assembly comprises three parts, including a first sliding member (330 or 430) that is interlocked with a second sliding member (340 or 440). The proximal end of the second sliding member is captured by a proximal body (350 or 450) that is able to rotate relative to the second sliding member, but is not able to move axially or laterally relative to the sliding member. It can also be seen that each of the assemblies includes a threaded distalmost end, and also threads on the proximal end, on the rotating body. As shown in FIGS. 21 A and 21 B, the assemblies 320 and 420 are shown with substantially complete engagement sections 326 and 426, respectively. It can be seen in these figures that the proximal sliding member X40 is shown abutted against a travel stop of the distal sliding member X30.

FIGS. 22 and 23 show close up cross sectional representations of the proximal ends of assemblies 320 and 420, respectively. Referring to FIG. 22A, it can be seen that a receptacle or pocket 343 extends from the proximal most end 341 b to the tool inner coupling shape 348b. The proximal face of tool coupling shape 348b is located distally to transverse through holes 345 and 555, which are shown aligned in FIGS. 22A and 22B. The pocket shape X43 is adapted and configured for receiving the end of the tool for tightening and application of torque to member X40, or in some embodiments for placement of a locking assembly X90.

FIG. 22B shows the device of FIG. 22A after a locking assembly 390 has been inserted into pocket 343. In one embodiment, locking assembly 390 includes an expanding member 392 received within an expandable member 394. In some embodiments, the members 392 and 394 are coupled together by a threaded interface 396.

Expanding member 394 in one embodiment includes a distal, flexible section that includes one or more projections or pawls 396. In the free-state, these pawls 396 have a combination of flexibility and outermost dimension that permit sliding of expanding assembly 394 into pocket 343 of member 340. In some embodiments, the expanding member 394 is manufactured such that the flexible section with the projections has a free-state in which the projections do not interfere with insertion in the pocket 343.

When fully inserted (as shown in FIG. 22B) the free-state pawls are at an axial location such that they are generally aligned with apertures 345 and 355. As expanding member 392 is driven into expandable member 394, it can be seen that the distal end 392a comes into contact with one or more flexible arms 394a. As member 392 is driven in a distal direction, the flexible members 394a are pushed outwardly by end 392a, such that at least one pawl 396 is forced into and through aligned apertures 345 and 355. When this is accomplished, the interference of the pawl 396 with the apertures 345 and 355 prevent relative axial movement, and also prevent relative rotational movement, of member 350 relative to member 340. It is further understood that the use of a locking assembly X90 is further contemplated for the implant configuration shown in FIG. 23.

FIGS. 24, 25, 26, and 30 depict various aspects of tools according to various embodiments of the present invention. These tools X80 are useful for both insertion and removal of the various devices X20 shown herein. FIG. 24A shows a tool assembly 180 adapted and configured to manipulate a bone implant, such as femur intramedullary nail 320. FIG. 24B is a perspective representation of a tool assembly 680 useful for manipulating an implant such as a tibia intramedullary nail 420. It is understood that the methods and apparatus shown and described for the various embodiments of the tools X80 shown herein can be used for implants other than the nails and screws X20 shown herein.

Discussion will be provided as to tool assembly 180, although it is understood, and further indicated by XNN element numbering, that similar features are provided with tool assembly 680, except as shown and described differently.

FIG. 24A shows a tool assembly 180 comprising three components, includes an outer sleeve 185a, an inner sleeve 185b that includes a handle 187, and a spring 188 that biases the inner joined or welded assembly of sleeve 185b and handle 187 relative to outer sleeve 185a. A fourth component internal rod 183 extends within the inner sleeve 185b, and as shown in FIGS. 24A and 26A, extends outwardly from both the distal and proximal ends of inner sleeve 185b. It is understood that the proximal end of rod 183 is adapted and configured in some embodiments to couple to a tool (not shown) that permits the surgeon to apply torque to rod 183. The distalmost end of the rod includes an end feature adapted and configured to mate with the bone implant (such as the proximal sliding member), and transmit that torque from the surgeon to the distalmost thread of the implant.

FIGS. 25A and 25B show exploded views of three of the components of tool assembly 180. The inner sleeve assembly comprising cylindrical section 185b and handle or collar 187 are shown prior to being welded together. Inner sleeve 185b is received within a preferably cylindrical inner passage of outer sleeve 185a. Inner sleeve handle 187 is received within a proximal side handle pocket 184 that includes a pair of opposing grooves that are adapted and configured to guide within them the opposing projections 187a of inner sleeve handle 187 (the placement of the projections within the grooves is best seen in FIGS. 24A and 24B). Prior to welding the cylindrical section 185b to the endcap 187, a spring 188 is inserted within the proximal pocket of handle section 184, as best seen in FIGS. 26A and 26B. It is understood that the two components for the inner sleeve can be joined by welding, brazing, adhesives, locking threads, or any other method.

A rod 183 extends within the length of the central channel of the cylindrical portion of the inner sleeve, as best seen in FIG. 26A. The proximal end of rod 183 includes an end stop 183a that abuts against handle 187, so as to limit the distal- direction movement of rod 183. An inner tool end 186a extends out of the distalmost end of assembly 180, tool 186a being adapted and configured to provide a driving torque onto a bone implant, such as onto the proximal end of the proximal sliding member X40.

FIGS. 27 and 28 present various views of a bone screw 520 according to another embodiment of the present invention. It is understood that the use of the X numbering system indicates a number of similarities between the fastener or screw 520, and the various intramedullary nails X20 shown herein. Bone screw 520 shares such

similarities, but is different as will be shown in the figures and described.

FIGS. 27A and 27B show perspective outer and cross sectional views, respectively, of a fastener 520 according to one embodiment of the present invention. Fastener 520 preferably includes a distal sliding member 530 and proximal sliding member 540 that are slidingly coupled so as to guide one another on a path generally indicated by a longitudinal or central axis 522. The two member 530 and 540 are coupled together along a guided length 526. As noted for the various nail assemblies X20, the two member 530 and 540 are free to slide relative to each other, until any of the internal travel stops are reached. It is understood that the cross sectional shapes of members 530 and 540 can be any of the types of shapes described herein.

Rotatably coupled to the proximal end of proximal member 540 is a rotating body 550. As can be seen in FIG. 27B, in some embodiments the members 550 and 540 are coupled to one another by a coupling wire 560. Preferably, rotating body 550 can be coupled by external threads 557 to a bone. Because of the ability of member 550 to rotate relative sliding member 540, the fixation and tightening of threads 550 into a bone does not transmit a torque (except by friction) onto the slidingly coupled member 540 and 530.

However, in a manner similar to that expressed and shown for nail assemblies X20, a torque can be applied to a coupling shape 548b, with this torque being transferred along length 526 to the threads 537 of distal member 530. In this manner, the distal end of screw 520 can be driven and tightened into one bone or bone fragment, and the threads 557 can be driven into another adjacent bone or bone fragment and coupled thereto by threads 557. Bone screw 520 will restrain any relative rotation between the two bones or bone fragments, but permitting axial movement (such as growth) between the two bones or bone fragments.

FIGS. 30E, 30F, and 30G present various depictions of the distalmost end of tool assembly 180. FIG. 30E is a side elevational view of the generally cylindrical inner sleeve 185b. It can be seen that the distalmost end includes an end effector 186e that is adapted and configured to hold onto a bone implant that includes complementary- shaped features that are adapted and configured to releaseably couple to end effector 186e. It can be seen that the end effectors are formed into opposing halves of the cylindrical body of sleeve 185b. A lengthwise slit extends from the face of the end effector in an axial direction for a length sufficient to create a region of reduced hoop stiffness proximate to the end effector. Because of this, the two opposing halves of the cylindrical body can be elastically moved toward one another. By this radially inward movement, the end effector 186e can thereby place the radial-extending lip 186g around the periphery of the proximal end of the bone implant (as best seen in FIG.

30G). It can also be seen in these figures that there are gradually sloping surfaces along the length of the slit, and proximate to the end effector, and when the inner sleeve is received within the inner passage of the outer sleeve 185a, these angled surfaces result in a compression of the two opposing cylindrical halves, this compression being shown in FIG. 30G. However, when the user squeezes the handles 184 and 187 together, the distal end of the inner sleeve is pushed out of the distal end of the outer sleeve, and the two cylindrical halves are able to separate to a free shape that is larger than the compressed shape that grips the bone implant. FIG. 30D likewise shows the end effectors 186e in a state where they are compressed together and gripping a bone implant.

Tool 680 includes a different manner of gripping a bone implant. Referring to FIGS. 24B, 30A, 30B, and 30C, it can be seen that end effectors 386e are adapted and configured to be slidingly received within a dovetail groove. In one embodiment, including the proximal member 450, it is understood that the tool coupling features 458b shown in FIG. 23, and further expressed in plan view form in FIG. 13A (Y-shape) have side walls that are slightly angled in a dovetail manner. Referring to FIG. 30B, it can be seen that one of the end effectors 386e (the bottom shaft of the Y-shape) likewise has a complementary-shape dovetail cross section, and is slidingly received within the dovetail of member 450. The opposite end effectors (with the open Y-shape) are seen in FIG. 30C. In a manner similar to that described for tool 180, the axial movement of the inner sleeve 685b within outer sleeve 685a results in alternating between compression of end effectors 686e and relaxation (outward expansion) of the end effectors, thereby gripping or releasing, respectively, the end of a bone implant.

Various aspects of different embodiments of the present invention are expressed in paragraphs X1 , X2, X3, X4, and X5 as follows:

X1. One aspect of the present invention pertains to a device implantable in the intramedullary canal of a bone. The device preferably includes a first elongated sliding member having a first distal end and a first proximal end and a first cross sectional shape therebetween. The device preferably includes a second elongated sliding member having a second distal end and a second proximal end and a second cross sectional shape therebetween, the second cross sectional shape being adapted and configured to slidingly interlock with the first cross sectional shape, wherein the first sliding member and the second sliding member are prevented from relative rotation when slidingly interlocked. The device preferably includes a third member having a third distal end and a third proximal end, the third member being rotatable and/or lockable about the second proximal end.

X2. Another aspect of the present invention pertains to a device implantable in the intramedullary canal of a bone. The device preferably includes a first elongated sliding member having a first distal end and a first proximal end and a first cross sectional exterior shape therebetween. The device preferably includes a second elongated sliding member having a second distal end and a second proximal end and a second cross sectional interior shape therebetween, the second interior shape being adapted and configured to slidingly receive within it the first exterior shape, wherein the first sliding member and the second sliding member are limited to relative rotation of less than about one complete revolution when slidingly coupled together. The device preferably includes a third member having a third distal end and a third proximal end, the third member being rotatable and/or lockable about the second proximal end.

X3. Yet another aspect of the present invention pertains to a device for securement to a bone. The device preferably includes a first elongated sliding member having a first distal end and a first proximal end and a first cross sectional shape therebetween, the first distal end including threads adapted and configured to engage a bone. The device preferably includes a second elongated sliding member having a second distal end and a second proximal end and a second cross sectional shape therebetween, the second proximal end including a tool coupling feature adapted and configured to receive an applied torque, the second cross sectional shape being adapted and configured to guide the first cross sectional shape. The device preferably includes a third member being captured on the second proximal end and being freely rotatable about the second proximal end, the third distal end including threads adapted and configured to engage a bone.

X4. Still another aspect of the present invention pertains to a kit for orthopedic surgery. The kit preferably includes a bone implant, including a first elongated sliding member having a first distal end and a first proximal end and a first cross sectional shape therebetween, the first distal end including threads adapted and configured to engage a bone; a second elongated sliding member having a second distal end and a second proximal end and a second cross sectional shape therebetween, said second proximal end including a first tool coupling feature, said second cross sectional shape being adapted and configured to slidingly couple with the first cross sectional shape; and a third member having a third distal end and a third proximal end, said third member being rotatable about the second proximal end, the third distal end including threads adapted and configured to engage a bone, the third proximal end including an aperture that extends completely through said third member, the second proximal end being receivable within the aperture. The kit preferably includes a tool for implanting said bone implant, including an outer sleeve having an inner passage; an inner sleeve having a central channel and a fourth proximal end with an outer diameter receivable within the inner passage, and a fourth distal end having a free shape that is larger than the inner passage, said fourth distal end being elastically compressible to a compressed shape that is receivable within the inner passage, the fourth distal end being adapted and configured to grip the periphery of said third member when compressed; and a rod having a distal end with a second tool coupling feature adapted and configured to couple with the first tool coupling feature and transmit a torque from said rod to said second sliding member, said rod being received within the central channel.

X5. Yet another aspect of the present invention pertains to a tool for manipulating two bone implants. The tool preferably includes an outer sleeve a first distal end and having an inner passage. The tool preferably includes an inner sleeve movable within the inner passage and having a central channel and a second proximal end with an outer diameter slidable within the inner passage, and a second distal end having a free shape that is larger than the inner passage, said second distal end being elastically compressible to a compressed shape that is receivable within the inner passage, the second distal end being adapted and configured to grip an end of one bone implant when compressed and to not grip the end of the one bone implant when in the free shape. The tool preferably includes a rod having a distal end with a tool coupling feature adapted and configured to couple with the other bone implant and transmit a torque from said rod to the other bone implant, said rod being rotatable within the central channel. The tool preferably includes a spring biasing said inner sleeve in a direction relative to outer sleeve to move the second distal end toward the inner passage.

X6 Yet another aspect of the present invention pertains to a device

implantable in the intramedullary canal of a bone. The device preferably includes a first elongated sliding member having a first distal end and a first proximal end and a first cross sectional shape therebetween, the first cross sectional shape being one of male or female; the first distal end including threads adapted and configured to engage an interior of a bone. The device preferably includes a second elongated sliding member having a second distal end and a second proximal end and a second cross sectional shape therebetween, the second cross sectional shape being the other of male or female; one of the second cross sectional shape or the first cross sectional being adapted and configured to slidingly receive within it the other cross sectional shape. The device preferably includes a third member having a third distal end and a third proximal end, said third member being rotatable about at least one of the first proximal end or the second proximal end, the third distal further being lockable relative to at least one of the first proximal end or the second proximal end.

Yet other embodiments pertain to any of the previous statements X1 , X2, X3, X4, X5 or X6 which are combined with one or more of the following other aspects. It is also understood that any of the aforementioned X paragraphs include listings of individual features that can be combined with individual features of other X paragraphs.

Wherein said third member is rotatable about the second proximal end by more than one complete revolution.

Wherein said first cross sectional shape is not circular and said second cross sectional shape is not circular.

Wherein said first cross sectional shape has a maximum dimension, said second cross sectional shape has a minimum dimension, and the maximum dimension is greater than the minimum dimension.

Wherein the third member is restrained from movement along the length of said second elongated member by obstruction between said third member and the second proximal end.

Wherein said third member is rotatable about the second proximal end by more than one complete revolution.

Which further comprises a separable retention member located between the second proximal end and said third member, said retention member restraining axial movement of said third member relative to said second member but permitting rotational movement of said third member relative to said second member.

Wherein said third member can rotate relative to said second member by more than 360 degrees.

Wherein said retention member is a wire.

Wherein at least one of said second member or said third member includes a groove and said retention member is located within the groove.

Wherein the other of the second member or third member includes a groove, and the two grooves face each other and form a channel for receiving therein said retention member.

Wherein one of said first sliding member or said second sliding member includes a shoulder that limits the length of the sliding interlocking.

Wherein the second proximal end has a shape adapted and configured to mate with a second tool for rotation of said first sliding member.

Wherein the third proximal end has a shape adapted and configured to mate with a third tool for rotation of said third member. Wherein said third member includes an aperture receiving therein the second proximal end, the second proximal end having a shape adapted and configured to mate with a second tool for rotation of said first sliding member.

Wherein the shape of the third proximal end is a shape around the periphery of said third member.

Wherein the shape of the third proximal end is a shape on the proximal face of said third member.

Wherein the third proximal end includes a receptacle for receiving therein the second proximal end, the second proximal end being externally accessible.

wherein the interlocking of said first member to said second member defines a central axis, and the second proximal end has a second through aperture that is non- parallel to the axis and said third member has a third aperture that is non-parallel to the axis, and said third member can be rotated about said second member so that the second through aperture can be aligned with the third aperture.

Which further comprises a fourth member adapted and configured to be received within the aligned second and third apertures.

Wherein said fourth member is a bone screw.

Wherein said fourth member is an elongated pin.

Wherein the third aperture is a through aperture and said fourth member extends into bone adjacent to said third member

Wherein the second through aperture is an elongated slot, and the third through aperture is an elongated slot.

Wherein said second member includes an internal bore along the central axis and which further comprises a locking assembly receivable within the internal bore, said locking assembly including a pawl receivable within the aligned second and third apertures and adapted and configured to discourage relative rotation of said third member and said second member.

Wherein the second proximal end of said second member includes an internal bore along the central axis and which further comprises a locking assembly insertable within the internal bore, said locking assembly including a flexible portion that can be moved into the aligned second and third apertures.

Wherein the second proximal end of said second member includes an internal bore along the central axis and which further comprises an expandable locking body insertable within the internal bore and a threaded member receivable within said locking body, wherein the threaded insertion of said fastener within said locking body expands said locking body into a tight fit within the internal bore.

Wherein the second proximal end of said second member includes an internal bore along the central axis and which further comprises a locking body insertable within the internal bore and having a flexible section and a threaded member receivable within said locking body, wherein the threaded insertion of said fastener within said locking body bends the flexible portion into the aligned second and third apertures.

Wherein the first cross sectional shape is complementary to the second cross sectional shape, or wherein the first cross sectional shape is one of male or female, and the second cross sectional shape is the other of male or female.

Wherein the first member and the second member slide along a longitudinal axis, and the first cross sectional shape is identical to the second cross sectional shape rotated 180 degrees about the longitudinal axis.

Wherein the bone is a long bone, any two adjacent bones, or any adjacent bone fragment.

While the inventions have been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that only certain embodiments have been shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected.