CA2391062C - Radially expandable intramedullary nail - Google Patents

Radially expandable intramedullary nail Download PDF

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Publication number
CA2391062C
CA2391062C CA002391062A CA2391062A CA2391062C CA 2391062 C CA2391062 C CA 2391062C CA 002391062 A CA002391062 A CA 002391062A CA 2391062 A CA2391062 A CA 2391062A CA 2391062 C CA2391062 C CA 2391062C
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CA
Canada
Prior art keywords
intramedullary nail
section
head
longitudinal axis
radially expandable
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
CA002391062A
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French (fr)
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CA2391062A1 (en
Inventor
Stephan Perren
Markus Hehli
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Synthes USA LLC
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Synthes USA LLC
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Filing date
Publication date
Application filed by Synthes USA LLC filed Critical Synthes USA LLC
Publication of CA2391062A1 publication Critical patent/CA2391062A1/en
Application granted granted Critical
Publication of CA2391062C publication Critical patent/CA2391062C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72Intramedullary pins, nails or other devices
    • A61B17/7233Intramedullary pins, nails or other devices with special means of locking the nail to the bone
    • A61B17/7258Intramedullary pins, nails or other devices with special means of locking the nail to the bone with laterally expanding parts, e.g. for gripping the bone
    • A61B17/7266Intramedullary pins, nails or other devices with special means of locking the nail to the bone with laterally expanding parts, e.g. for gripping the bone with fingers moving radially outwardly

Abstract

Intramedullary nail for fixation of bone fractures with a head (1), a tip (2) and a longitudinal axis (3), whereby a first radially expandable section (5) is provided in the proxi-mal section (4) adjacent to the head (1) of the in-tramedullary nail; a second radially expandable section (7) is provided in the distal section (6) adjacent to the tip (2) of the intramedullary nail;
and a non-expandable middle section (8) is pro-vided between said two radially expandable sec-tions (5, 7) of the intramedullary nail.

Description

RADIALLY EXPANDABLE INTRAMEDULLARY NAIL

This invention concerns an intramedullary nail for the treatment of bone fractures.
Various types of intramedullary nails are already known in the state of the art, which are expandable in a limited section of the nail in order to allow the fixation of the nail against the bone cortex, e.g. by means of radially deploying a number of blades in the distal portion of the intramedullary nail.

The disadvantages of these known devices consist in:
a) The fact that the nail is not extrafocal and so is not consistent with the state of art concept of fracture treatment. The largest expansion of the nail is in the fracture area, which affects negatively the endosteal vascularisation just in the fracture area, i.e. the most important area;
b) The largest expansion of the nail in the fracture area generates forces which have the tendency to separate the fragment in comminuted fractures or, in the case of longitudinal non-dislocated fractures to increase the gap and to dislocate fragments which leads to loosening of the fixation.

The present invention aims at solving the above described problems and disadvantages.

The present invention provides an intramedullary nail having a head, a tip, and a longitudinal axis for fixation of a fractured bone having a medullary canal, the intramedullary nail comprising a first radially expandable section adjacent to the head, a second radially expandable section adjacent to the tip, and a non-expandable section disposed between the first and second radially expandable sections, wherein the first and second radially expandable sections each comprise a slotted tubular member.

The nail according to the invention allows to obtain the following advantages:
a) The expandable parts of the nail are located extrafocally, leaving the fracture area minimally affected from radial forces;

la b) the nail is particularly strong in the middle part - between the proximal and distal sections - of the nail c) no fluoroscopy is needed for distal nor proximal locking since the expandable parts are fastened via tightening a nut on a thread in the longitudinal direction of the intramedullary nail.
The intramedullary nail according to the invention comprises a first radially expandable section provided in the proximal section adjacent to the head of the intramedullary nail, a second radially expandable section provided in the distal section adjacent to the tip of the intramedullary nail and a non-expandable middle section provided between said two radially expandable sections of the intramedullary nail.

The head provides a distraction mechanism, by means of which said two radially expandable sections are distractible transverse to said longitudinal axis.

In a preferred embodiment of the intramedullary nail according to the invention the non-expandable section of the intramedullary nail has a length in the range of to 25 mm, preferably in the range of 15 to 22 mm.

Furthermore, the intramedullary nail consists of a solid nail core with a head and a tip.
In the proximal section adjacent to the head a thread is provided. The middle section of the core is configured with a smaller diameter than the end section of the core such that the middle section and the end section are separated by an annular abutment. Apart from the core the intramedullary nail according to this embodiment comprises two longitudinally slotted tubular pieces that provide the first and second radially expandable sections, two unslotted tubular pieces and a nut. These elements are slid over the core in the following sequence:
- a slotted tubular piece - an unslotted tubular piece - a slotted tubular piece - an unslotted tubular piece such that adjacent to the tip of the nail a first slotted tubular piece is provided. The second slotted tubular piece is separated from the first one by means of an unslotted tubular piece. Adjacent to the end of the nail a nut with an interior thread corresponding to a thread on the core is mounted such allowing to compress the tubular pieces along the longitudinal axis. When these element are aligned on the core a screwing of the nut onto the thread on the core - by means of a driving means such as a spanner, wrench or similar tool engaged to suitable means at the nut such as two parallel sides, hexagonal sides, a hexagon socket or the like - and holding up the core against rotation - by means of a second tool inserted into corresponding suitable means at the core such as a slot, hexagon socket or the like - will produce an axial force or compression on the tubular pieces as soon as the first slotted tubular piece abuts against the abutment of the core and the nut is tightened.
Under that compression force the belts between the cuts at the slotted tubular pieces begin to buckle and deform radially such causing a radial expansion of the slotted tubular pieces. By this effect the nail expands at a first radially expandable section in the proximal section adjacent to the head of the nail and in a second radially expandable section in the distal section adjacent to the tip of the nail.

A further embodiment of the intramedullary nail according to the invention differentiates from the above embodiment therein that it provides instead of the core a hollow cylindrical or prismatical sleeve extending along the longitudinal axis and surrounding a rodlike locking element coaxially to the longitudinal axis. The locking element comprises a shaft with a thread in the proximal section towards the head of the nail and a projection forming an abutment in the distal section.
In the distal section the sleeve provides a slot penetrating the side wall through to the bore such that the projection of the locking element may slide within said slot in the direction of the longitudinal axis. Once the tubular elements are aligned on the sleeve as mentioned above the tightening of the nut on the thread on the locking element while holding up the locking element against rotation causes a compression force onto the tubular elements clamped between the nut and the abutment producing the same effect as described in the above embodiment of the intramedullary nail.

A third preferred embodiment of the intramedullary nail comprises five elements:
a nut, a hollow proximal section, a hollow middle section and a hollow distal section and a central wire. Contact between the proximal section and the middle section is represented by first abutments transversely arranged relative to the longitudinal axis while contact between the middle section and the distal section is represented by second abutments transversely arranged relative to the longitudinal axis. The central wire is fixed in the distal section and runs through a hollow channel of the other sections. At its proximal end the central wire provides threads which correspond to the interior threads of the nut.
When the nut is tightened a sliding of the proximal section and distal section on the first and second transverse abutments respectively is produced. If the intramedullary channel of the femur has a larger in diameter than the intramedullary nail the proximal section and distal section will expand transversely to the longitudinal axis until firm fixation of the bone fragments is reached. This radial expansion is possible because the first and second transverse abutments enclose an angle of between 50 and with the longitudinal axis such that upon applying a force in the axial direction by means of tightening the nut the proximal section, the middle section and the distal section slide on the abutments providing a sliding component orthogonal to the longitudinal axis what causes a radial expansion of the intramedullary nail.

The middle section may provide sharp radial teeth that prevent axial displacement of the bone fragments after fixation of the nail.

Yet, another embodiment of the intramedullary nail according to the invention comprises basically three elements: a nut with a head and a conical tip, a central wire with a cone like distal end and a hollow intramedullary nail. The ends of the intramedullary nail are provided with a plurality of cuts such forming contact studs that are radially expandable within the intramedullary channel of the bone. The central wire runs through the hollow channel of the intramedullary nail and - at its proximal end - has threads which correspond to the interior threads of the nut. When the nut is tightened the distance between the conical tip of the nut and the cone like distal end of the central wire is shortened, so that the contact studs of the intramedullary nail are expanded by means of the radial forces caused by the axial displacement of the cones. This expansion of the intramedullary nail proximally and distally produces a firm fixation of the bone fragments of the femur.

The various features of novelty which characterize the invention are pointed out with particularity in the claims annexed to and forming part of this disclosure. For the better understanding of the invention, its operating advantages and specific objects attained by its use, reference should be had to the accompanying drawings, examples and descriptive matter in which are illustrated and described preferred embodiments of the invention.
In the drawings:

Fig. 1 shows a schematic representation of an intramedullary nail according to the invention in the non-expanded state;

Fig. 2 shows an exploded view of the intramedullary nail according to Fig. 1;

Fig. 3 shows a schematic representation of one of the expandable sections of the intramedullary nail according to Fig. 1 in the non-expanded and in the expanded state;
Fig. 4 shows a schematic representation of an intramedullary nail according to the invention in the expanded state;

Fig. 5 shows a second embodiment of an intramedullary nail according to the invention;

Fig. 6 shows a variation of the nut to be used with the intramedullary nail according to Fig. 5;

Fig. 7 shows a third embodiment of an intramedullary nail according to the invention and in the non-expanded state;

Fig. 8 shows the intramedullary nail according to Fig. 7 in the expanded state;

Fig. 9 shows the intramedullary nail according to Fig. 7 implanted in a femur bone and in the expanded state;

Fig. 10 shows a fourth embodiment of an intramedullary nail according to the invention in the expanded state; and Fig. 11 shows a the intramedullary nail according to Fig. 10 implanted in a femur bone and in the expanded state.
Figures 1 to 4 show a first embodiment of the invention which consists of a solid nail core 10 with a head 1 and a tip 2 and a longitudinal axis 3. In the proximal section 4 adjacent to the head 1 a tread 9 is provided. The middle section 13 of the core 10 has smooth surface and a tapering diameter towards the distal section 6 adjacent to the tip 2. The middle section 13 of the core 10 - with a minor diameter - and the end section 11 of the core 10 - with a larger diameter - are separated by an annular abutment 12.
As shown in Fig. 2 the following elements are slid over the core 10 in the following sequence:
- a slotted tubular piece 14 - an unslotted tubular piece 15 - a slotted tubular piece 16 - an unslotted tubular piece 17 - a nut 18 with an inner thread corresponding with thread 9.

When these element are aligned on the core 10 a screwing of the nut 18 - by means of the two parallel sides or hexagonal sides 22 - on the thread 9 and holding up the core 10 - by means of the slot 23 - will produce an axial force or compression (as indicated by arrows 19 in Fig. 3) on the tubular pieces (17,16,15,14) as soon as the slotted tubular piece 14 abuts against the abutment 12 of the core 10. As shown in Fig. 3 the cuts 20 of the slotted tubular piece 14 - as well as those of slotted tubular piece 16 - will cause an expansion of the slotted tubular piece 14 by radially deforming the belts 21 located between the cuts 20.

By this effect the nail expands - as shown in Fig. 4 - at a first radially expandable section 5 in the proximal section 4 adjacent to the head 1 of the nail and in a second radially expandable section 7 in the distal section 6 adjacent to the tip 2 of the nail. Instead of the two parallel sides or hexagonal sides 22 and the slot 23 for tightening the nut 18 two hexagon sockets may be placed.

Fig. 5 and 6 show a second embodiment of the intramedullary nail which differentiates from the embodiment shown in Fig. 1 - 4 therein that it provides instead of the core 10 a hollow cylindrical sleeve 35 extending along the longitudinal axis 3 and surrounding a locking element 32 coaxially to the longitudinal axis 3. The locking element 32 comprises a shaft with a thread 41 in the proximal section 4 and in the distal section 6 a projection 31 forming an abutment 39. In the distal section 6 the sleeve 35 provides a slot 34 penetrating the side wall through to the bore 33 such that the projection 31 of the locking element 32 may slide within said slot 34 in the direction of the longitudinal axis 3. The following elements are slid over the sleeve 35 in the following sequence:
- a slotted tubular piece 14 - an unslotted tubular piece 15 - a slotted tubular piece 16 - an unslotted tubular piece 17 - an end cap 42 - a nut 40 with an inner thread corresponding with thread 41.
Once these elements are aligned on the sleeve 35 the tightening of the nut 40 on the thread 41 while counter holding the locking element 32 by means of the hexagon socket 43 axially compresses the tubular pieces 14;15;16;17 as soon as the slotted tubular piece 14 abuts against the abutment 39 formed by the projection 31 of the locking element 32. Equally as in case of the first embodiment the belts 21 of the slotted tubular pieces (14;16) buckle and radially expand under the axial forces 19 (Fig. 3). Instead of the nut 40 and the end cap 42 another end cap 36 providing in interior thread 38 corresponding with thread 41 and a hexagon socket 37 may be used (Fig. 6).

Figs. 7 to 9 show a third embodiment of the intramedullary nail which consists basically of five elements: a nut 50, a hollow proximal section 51, a hollow middle section 52 and a hollow distal section 53 and a central wire 54. Contact between the proximal section 51 and the middle section 52 is represented by transverse abutments 55 (relative to the longitudinal axis 3). Contact between middle section 52 and distal section 53 is represented by transverse abutments 56 (relative to the longitudinal axis 3). The central wire 54 is fixed in the distal section 53 and runs through the hollow channel 59 of sections 51,52,53. At its proximal end the central wire 54 has threads 57 which correspond to the interior threads 58 of the nut 50. When the nut 50 is turned by means of a key 60 the central wire 54 is tightened and produces sliding of the proximal section 51 and distal section 53 on the transverse abutments 55 and 56 respectively. If the intramedullary channel 61 of the femur 62 (Fig. 9) has a larger in diameter than the intramedullary nail the proximal section 51 and distal section 53 will expand radially until firm fixation of the bone fragments 63 and 64. This radial expansion is possible because the transverse abutments 55;56 enclose an angle of between 5 and 85 with the longitudinal axis 3 such that upon applying a force in the axial direction by means of tightening the nut 50 the proximal section 51, the middle section 52 and the distal section 53 slide on the abutments 55;56. Because the abutments 55;56 enclose an angle with the longitudinal axis the sections 51;52;53 opposing each other at one abutment 55;56 each provide a sliding component orthogonal to the longitudinal axis 3 what causes a radial expansion of the intramedullary nail.

The sharp radial teeth 65 in the middle section 52 prevent axial displacement of the bone fragments 63,64 after its fixation.

Figs. 10 and 11 show a fourth embodiment of the intramedullary nail which consists basically of three elements: a nut 71 with head 1 and conical tip 78, a central wire 72 with a cone like distal end 73 and a hollow intramedullary nail 79. The ends of the intramedullary nail 79 are provided with a plurality of cuts 74. The central wire 72 runs through the hollow channel 75 of the intramedullary nail 79 and - at its proximal end - has threads 76 which correspond to the interior threads 77 of the nut 71.
When the nut 71 is turned by means of a key 60 the distance between the conical tip 78 of the nut 71 and the cone like distal end 73 of the central wire 72 is shortened, so that the cuts 74 of the intramedullary nail 79 are expanded as shown in Fig. 11. The expansion of the intramedullary nail 79 proximally and distally at sections 5 and 7 produces a firm fixation of the bone fragments 63 and 64 of the femur 62.

While the foregoing description and drawings represent the preferred embodiments of the present invention, it will be obvious for those skilled in the art that various changes and modifications may be made therein without departing from the scope of the present invention.

Claims (33)

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:
1. An intramedullary nail having a head, a tip, and a longitudinal axis for fixation of a fractured bone having a medullary canal, the intramedullary nail comprising:
a first radially expandable section adjacent to the head;
a second radially expandable section adjacent to the tip; and a non-expandable section disposed between the first and second radially expandable sections;
wherein the first and second radially expandable sections each comprise a slotted tubular member.
2. The intramedullary nail of claim 1, wherein the head is provided a distraction mechanism, and the first and second radially expandable sections are distractible transverse to said longitudinal axis.
3. The intramedullary nail of claim 1, wherein the non-expandable section has a length in the range of about 10 mm to 25 mm.
4. The intramedullary nail of claim 1, wherein the slotted tubular members are configured to be slidable on a sleeve.
5. The intramedullary nail of claim 1, wherein the non-expandable section comprises one unslotted tubular member.
6. The intramedullary nail of claim 5, wherein the non-expandable section of the intramedullary nail has a length in the range of about 15 mm to about 22 mm.
7. The intramedullary nail of claim 1, further comprising a hollow cylindrical sleeve extending along the longitudinal axis and surrounding a locking element coaxially to the longitudinal axis.
8. The intramedullary nail of claim 7, wherein the locking element comprises a shaft with a thread in a proximal section and a projection forming an abutment in the a distal section.
9. The intramedullary nail of claim 7, wherein the sleeve comprises means for engagement of a holding means.
10. The intramedulllary nail of claim 9, wherein the means for engagement of a holding means is a slot.
11. The intramedullary nail of claim 7, wherein the head is provided with a distraction mechanism comprising a thread on the locking element adjacent to the head and a nut with an interior thread corresponding with the thread on the locking element.
12. The intramedullary nail of claim 11, wherein the nut comprises means for engagement of a driving means.
13. The intramedullary nail of claim 7, wherein the locking element comprises means for engagement of a holding means.
14. The intramedullary nail of claim 13, wherein the head is provided with a distraction mechanism comprising a thread on the locking element adjacent to the head and an end cap with an interior thread corresponding with the thread on the locking element.
15. The intramedullary nail of claim 14, wherein the end cap comprises means for engagement of a driving means.
16. An intramedullary nail having a head, a tip, and a longitudinal axis for fixation of a fractured bone having a medullary canal, the intramedullary nail comprising:

a first radially expandable section adjacent to the head;
a second radially expandable section adjacent to the tip; and a non-expandable section disposed between the first and second radially expandable sections;
wherein the expandable and non-expandable sections are tubular members that are positioned over a sleeve in sequence and are secured on the sleeve by a nut, the sequence of positioning the tubular members comprising: a slotted tubular member, an unslotted tubular member, a slotted tubular member, and an unslotted tubular member.
17. The intramedullary nail of claim 16, wherein the nut comprises means for engagement of a driving means.
18. The intramedullary nail of claim 17, wherein the means for engagement of a driving means comprises hexagonal sides.
19. An intramedullary nail having a head, a tip, and a longitudinal axis for fixation of a fractured bone having a medullary canal, the intramedullary nail comprising:
a first radially expandable section adjacent to the head;
a second radially expandable section adjacent to the tip;
a non-expandable section disposed between the first and second radially expandable sections; and a hollow cylindrical sleeve extending along the longitudinal axis and surrounding a locking element coaxially to the longitudinal axis;
wherein the locking element comprises a shaft with a thread in a proximal section and a projection forming an abutment in a distal section;
and wherein a distal section of the sleeve provides a slot penetrating a side wall through to a bore and the projection of the locking element is movable to slide within said slot in the direction of the longitudinal axis.
20. An intramedullary nail for fixation of a fractured bone having a medullary canal, the intramedullary nail comprising:
a central member comprising a proximal section with a head, a distal section with a tip, and a longitudinal axis;
a first radially expandable member slidably disposed on the proximal section of the central member;
a second radially expandable member slidably disposed on the distal section of the central member; and a non-expandable section slidably disposed on the central member between the first and second radially expandable sections.
21. The intramedullary nail of claim 20, wherein the first and second radially expandable sections each comprise a slotted tubular member.
22. The intramedullary nail of claim 20, wherein the head is provided with a distraction mechanism, and the first and second radially expandable sections are distractible with respect to each other.
23. The intramedullary nail of claim 20, wherein the non-expandable section comprises at least one unslotted tubular member.
24. The intramedullary nail of claim 20, wherein the non-expandable section has a length in the range of about 10 mm to 25 mm.
25. The intramedullary nail of claim 20, wherein the non-expandable section has a length in the range of about 15 mm to about 22 mm.
26. The intramedullary nail of claim 20, wherein the head is provided with a distraction mechanism comprising a threaded portion and a nut threadably associated therewith.
27. The intramedullary nail of claim 26, wherein the nut comprises means for engagement of a driving means.
28. The intramedullary nail of claim 20, further comprising a hollow cylindrical sleeve disposed about the longitudinal axis and surrounding a shaft comprising a thread in a proximal section and a projection forming an abutment in the distal section.
29. The intramedullary nail of claim 28, wherein a distal section of the sleeve comprises a slot extending to a bore therein an the projection of the shaft is slidable within the slot in the direction of the longitudinal axis.
30. The intramedullary nail of claim 20, further comprising a hollow cylindrical sleeve extending about the longitudinal axis and surrounding a locking element.
31. The intramedullary nail of claim 30, wherein the expandable and non-expandable sections are tubular members that are disposed on the sleeve in sequence and are secured on the sleeve by a nut, the sequence comprising:
a slotted tubular member, an unslotted tubular member, and a slotted tubular member.
32. The intramedullary nail of claim 31, wherein the nut comprises means for engagement of a driving means.
33. The intramedullary nail of claim 32, wherein the means for engagement of a driving means comprises hexagonal sides.
CA002391062A 1999-11-11 1999-11-11 Radially expandable intramedullary nail Expired - Fee Related CA2391062C (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/CH1999/000532 WO2001034045A1 (en) 1999-11-11 1999-11-11 Radially expandable intramedullary nail

Publications (2)

Publication Number Publication Date
CA2391062A1 CA2391062A1 (en) 2001-05-17
CA2391062C true CA2391062C (en) 2008-01-08

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US (1) US6736818B2 (en)
EP (1) EP1227765B1 (en)
JP (1) JP4156839B2 (en)
AT (1) ATE294538T1 (en)
AU (1) AU774717B2 (en)
CA (1) CA2391062C (en)
DE (1) DE69925169T2 (en)
ES (1) ES2241331T3 (en)
WO (1) WO2001034045A1 (en)

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