WO1997018769A1 - Intramedullary nail - Google Patents

Intramedullary nail Download PDF

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Publication number
WO1997018769A1
WO1997018769A1 PCT/FR1996/001842 FR9601842W WO9718769A1 WO 1997018769 A1 WO1997018769 A1 WO 1997018769A1 FR 9601842 W FR9601842 W FR 9601842W WO 9718769 A1 WO9718769 A1 WO 9718769A1
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WO
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Application
Patent type
Prior art keywords
axial
intramedullary nail
expandable
characterized
end rings
Prior art date
Application number
PCT/FR1996/001842
Other languages
French (fr)
Inventor
Pierre Alain Carruzzo
Gérard Saillant
Jean Godefroy
Original Assignee
Pierre Alain Carruzzo
Saillant Gerard
Jean Godefroy
Priority date (The priority date 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 date listed.)
Filing date
Publication date

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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

An intramedullary nail (1) including an axial rod (2) supporting tubular spacers (9, 10) and expandable, releasable and interchangeable sleeves (3, 4) slidably mounted on the axial rod (2) between an axial abutment (6) and a control nut (8). Tightening the control nut (8) axially compresses the spacers (9, 10) and the expandable sleeves (3, 4), and thereby causes expansion of the expandable sleeves in order to lock the intramedullary nail (1) in the marrow cavity (11) of a bone (12). The expandable sleeves (3, 4) comprise a substantially continuous, tubular, flexible and expandable circumferential wall made of a biocompatible material and operative to prevent bone rehabitation inside the sleeves.

Description

intramedullary nail

TECHNICAL FIELD OF THE INVENTION The present invention relates to internal fixation devices for bone fractures of long bones, such intramedullary nail comprising an axial stem with expansion locking means

Discloses déπà various types of intramedullary nails in expansion, and in particular those described in the following documents in the document US-A-4 858.602, the device comprises a hollow tubular body including a distal end having longitudinal slots An axial rod is engaged in the axial hole of the hollow body and has a distal head and a threaded proximal end engaged in a corresponding thread of the tubular body and accessible for being screwed by an external screwdriver through a side hole of the tubular body such a device allows a locking expansion that has the distal end of the device, and requires having the distal end in a portion of bone which the medullary canal has a substantially circular section II is not possible to ensure a fixing by expansion of other parts of the same channel, and it is not possible to effectively lock the device in portions of channel has flattened section Subsequent extraction of the device is difficult

FR-A-2 289 155 describes a similar device wherein a hollow tubular body receives an axial rod enabling, pai screwing, axially moving a nut bearing deformable oblique tongues can exit through lateral slots of the tubular body, in the vicinity of one and the other of the tubular body ends This device allows locking by expansion in the vicinity of both ends of the tubular body, in fixed positions, it being noted that the lock requires the presence of a medullary canal section substantially circular subsequent extraction of the device is difficult

Document FR-A-2653006 discloses another device wherein a hollow tubular body receives a threaded axial rod itself bearing a plurality of expandable bushings Each expansible sleeve is formed of a ring freely mounted on a smooth portion of the axial rod, and a threaded ring threadably engaged on a threaded portion of the axial rod, both rings being connected by flexible amounts adapted to flex radially outwardly upon the approximation of rings from one another resulting from screwing of the axial rod. The bushings are locked in rotation by the fact that the uprights are engaged in lateral slots of the tubular body. This device allows to provide several expansion means distributed along the tubular body but the position of the expansion means is fixed, and the radial expansion directions are determined by the position of the slots, and not modifiable. Subsequent extraction of the device is difficult.

GB-A-2 268 068 discloses an intramedullary nail comprising a shaft with axial thrust bearing and threaded portion receiving a maneuvering nut. The rod carries two expandable sleeves slidably mounted and each having two end rings connected by an expansible central portion adapted to deform radially outwardly under the effect of axial compression of the expansion sleeve. The expandable core is formed of a plurality of struts connecting the end rings and separated by slots. Each end of expandable ring receives a hook-shaped tip, secured to the sleeve by axial engagement two longitudinal tongues force in longitudinal slots The connection of the ends of the bushings must be mechanically strong to allow a higher traction of the device to its extraction from the bone as a result it is not possible to easily modify the length of the sleeve after setting caps will also be noted that it is difficult to extract the nail from the bone after a usual implementation period that allowed bone healing DISCLOSURE oF INVENTION

The problem addressed by the present invention is to design a new structure intramedullary nail for easy extraction from the bone after an implementation period that enabled the satisfactory bone healing In this respect, the idea is the basis of the invention is to avoid the development of fibrous or bone parts inside the expandable sleeves, said fibrous or bone parts then opposing the contraction of the expansible sleeve for its sliding in the reduced section portions of the medullary canal

Another problem addressed by the present invention is to allow easy adjustment of the axial position of the expansion locking elements, and an adjustment of the radial expansion directions of the locking elements, so as to adapt the intramedullary nail according to the geometry of the channel to receive it is particularly important to be able to easily adjust the length between two expansion locking elements, and this setting should be performed intraoperatively, without requiring special tools

To achieve these objects and others, an intramedullary nail according to the invention comprises.

- an axial rod having, at its first end, an axial stop and, at its second end, a threaded portion receiving an actuating nut and having anti-rotation means of the axial rod,

- a plurality of removable and interchangeable adjacent elements, slidably mounted on the axial rod between the axial stop and the actuating nut, at least one of said plurality of adjacent elements being a removable and interchangeable expansible sleeve, mounted slidably along the axial rod between the axial stop and the actuating nut,

- the expansible sleeve having two rings sliding end on the axial rod and connected by an expansible central portion adapted to deform radially outwardly when the approximation of the end rings towards each other under the effect an axial compression of the expansion sleeve, the expansion sleeve having a tubular peripheral wall substantially continuous, flexible and expandable in a biocompatible material It has been found that the peripheral wall substantially continuous expansible sleeve provides a barrier preventing any development of tissue fibrous or bone inside the expansion sleeve This result is obtained even though the interstices between the space outside the sleeve and the space inside the socket, including interstices formed by the ends of the sleeve when 'are simply resting against adjacent interchangeable components Thus, it is not nec essary to provide an absolutely watertight wall or predict that sealed wall occupies the entire length of the intramedullary nail

The biocompatible material may for example be based on polyurethane or silicone, optionally fiber reinforced increasing its rigidity and / or its elastic stiffness

According to a first embodiment, the substantially continuous tubular peripheral wall may form the outer surface of the expansible sleeve, either by itself constituting the expansible central portion and the end rings of the socket, or by wrapping an expandable inner frame formed by the end rings connected by flexible uprights themselves adapted to flex radially outwardly.

According to another embodiment, the expandable sleeve may include an expandable frame formed by the end rings connected by flexible and molded amounts internally with a layer of biocompatible material forming the substantially continuous tubular wall

Preferably, means are provided for locking the end rings in axial rotation on the axial rod, and the axial securing means are provided between the corresponding ends of adjacent elements In this way, an axial traction on the intramedullary nail, after unscrewing the nut causes the radial contraction expandable sockets, facilitating the extraction of the nail out of the bone BRIEF DESCRIPTION oF DRAWINGS

Other objects, features and advantages of the present invention appear from the following description of particular embodiments, given with reference to the appended figures, in which - Figure 1 illustrates the positioning of an intramedullary nail according to one embodiment of the invention in a long bone,

- Figure 2 is an exploded view showing the various parts of an intramedullary nail according to a second embodiment of the present invention, - Figure 3 is a perspective view of the intramedullary nail view of Figure 2 in the retracted assembled position, the Figure 4 is a perspective view of a spacer according to one invention;

- Figure 5 is a perspective view of a nut according to the invention, -

- Figure 6 is a perspective view of an expansible sleeve reinforcement according to an embodiment in three longitudinal struts according to the invention;

- Figure 7 is a perspective view of an expansible sleeve frame with two longitudinal frame structure according to an embodiment of the present invention; - Figure 8 is a side view of the expansible sleeve reinforcement of Figure 7;

- Figure 9 is a side view in longitudinal section of an expansible sleeve according to one embodiment of the invention, in retracted position, - Figure 10 is a view in longitudinal section of the expansible sleeve of Figure 9, in the extended position, and Figure 11 is a perspective view of an expandable sleeve according to another embodiment of the invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS In the embodiment illustrated in Figure 1, an intramedullary nail 1 according to the invention comprises an axial shaft 2 bearing expansion locking means, for example the means 3 and 4

At its first end, the axial rod 2 comprises an axial stop 6 in the form of a head integral with the rod 2. At its opposite second end, the axial rod 2 has a threaded portion 7 receiving a maneuvering nut 8 second end of the rod 2 further comprises blocking means in rotation of the shaft, for example a cross slot on its end face for engaging a screwdriver the expansion locking means 3 and 4 are expandable sleeves removable and interchangeable slidably mounted on the axial rod between two axial stop 6 and the actuating nut 8.

Tubular spacers such that the spacers 9 and 10, removable and interchangeable, are also slidably mounted on the axial rod between two axial stop 6 and the actuating nut 8 The intramedullary nail 1 thus comprises a plurality of removable elements adjacent and interchangeable, constituted by the sleeves 3 and 4 and the webs 9 and 10.

The intramedullary nail 1 is engaged in the medullary canal of a long bone there 12 such as a humerus. The tightening of the adjusting nut 8 provides an axial compression of the assembly formed by the spacers 9 and

10 and the expansible sleeves 3 and 4 between the adjusting nut 8 and the thrust bearing 6, causing the radial expansion of the sleeves 3 and 4.

Figure 2 illustrates the components of an intramedullary nail 1 according to an embodiment three expandable sleeves 3, 4 and 5 in exploded form, while Figure 3 illustrates the same intramedullary nail in assembled form and the radially retracted We thus find axial rod 2 with its axial stop 6 and its threaded portion 7 the rod 2 can have a circular cross section, allowing free rotation of the members which are slipped onto it the diameter of the rod 2 may for example advantageously be of about 5 mm, the diameter of the head forming the axial stop 6 can be about 7.5 millimeters

Furthermore the axial rod 2, there is the nut 8, consisting of a threaded hollow cylindrical tube whose end 13 may comprise an outer face hexagon enabling its operation by an appropriate key A view on a larger scale of the nut 8 is shown in Figure 5, where we distinguish the axial bore 113 of the nut permitting the passage of the axial rod.

Figures 2 and 3, it also distinguishes the two spacers 9 and 10, each formed of a hollow cylindrical tube, and shown on a larger scale in Figure 4

Figures 2 and 3, we finally distinguishes three expandable sleeves 3, 4 and 5

An embodiment for the sleeves 3 and 4, for example for the bushing 3, is illustrated in larger scale in Figure 6 In this figure, there is shown an expansible sleeve reinforcement 3, comprising two end rings 14 and 15 shaped to slide over the axial shaft 2 and connected by three flexible longitudinal struts 16, 17 and 18 adapted to flex radially outwardly when the approximation of the end rings 14 and 15 towards each other under the effect of axial compression of the expansion sleeve 3. According to one embodiment providing suitable results, the end rings 14 and 15 may have an outer diameter of about 7 mm, with a central hole whose diameter is slightly greater than 5 millimeters for the passage of the axial rod 2 with a diameter of 5 millimeters. Flexible posts 16, 17 and 18 may have a thickness of about 1 mm in the radial direction, and a width of about 2 millimeters. In the rest position, the flexible leg 16, 17 and 18 may be slightly curved, with a convexity directed outwards, so must flex outwardly upon axial compression to approximate the end rings 14 and 15 toward one another.

In the embodiment illustrated in Figure 7, the armature of the expansible sleeve 5 is also formed from two end rings 14 and 15, but the end rings 14 and 15 are connected by only two longitudinal struts 16 and 17, diametrically opposite as in the embodiment of Figure 6, the longitudinal struts 16 and 17 are at rest, advantageously curved with a convexity directed outwards.

This embodiment of Figure 7 is advantageous to produce expansion in a diametral plane, so that this embodiment may be particularly suitable for the expansion lock in a portion of the medullary canal with an oblong cross-section, the posts 16 and 17 which engages in the peaks of the oblong for this, it is necessary to control the angular orientation of the expansion sleeve 5 and two uprights 16 and 17, to guide posts 16 and 17 facing the peaks of the oblong shape before tightening the nut 8 This can be achieved for example by providing, on the axial rod 2, and a flat on the end rings 14 and 15, a corresponding plate 19 or 20 engaging the flat surface of the rod axial 2 to prohibit the relative rotation of the expansion sleeve 5 around the axial rod 2

Such flat 19 or 20 may also be provided on the end rings 14 and 15 of the expansion sleeve 3 in the embodiment of Figure 6, however, in this case the expansion sleeve 3 produces an expansion in three radial directions regularly distributed around the longitudinal axis, so that such an expansible sleeve is particularly suitable for expansion into a medullary canal portion having a circular or round cross section, and control the angular orientation of the expansible sleeve is then not useful.

As indicated above, the radial outward bending of the uprights 16, 17 and 18 may be ensured by the fact that, in the rest position, the amounts are curved convex outwardly facing

Alternatively, one can provide amounts 16, 17 and optionally 18 having a coaxial helical If the propellers rotate in the same direction, it is then necessary to provide the rotational locking means of the end rings 14 and 15, by example by dishes 19 and 20 engaging the flat portion of the axial rod 2

For against, for example by providing two uprights 16 and 17 with reverse helical, it is possible to forego the rotational locking means of the end rings 14 and 15

In Figure 8, there is shown, in side view, the frame of the expansible sleeve 5 of Figure 7

In Figure 9 and in longitudinal section shows a preferred embodiment of the expansible sleeve 5 is found the entire end rings 14 and 15, and the flexible longitudinal struts 16 and 17 The frame of the expansible sleeve 5 is internally molded with a tubular layer 23 of a biocompatible elastic material such as polyurethane or a silicone layer 23 of resilient material comprises a substantially continuous tubular peripheral wall and opposed to bone ingrowth to one inside of the expansible sleeve 5 after implantation of the intramedullary nail 1 in a bone as shown in Figure 10, upon axial compression to approximate the end rings 14 and 15 from each other, flexible posts 16 and 17 flex by arching towards outside, and the layer 23 of flexible material following such deformation remaining attached to the uprights 16 and 17 it should be noted that in this mode r realization, the layer 23 of elastic material does not cover the external face of the uprights 16 and 17, so that contact is made directly between the uprights 16 and 17 and the bone

In Figure 11, there is shown in perspective another preferred embodiment of the expansible sleeve 5 Complete There is also the end rings 14 and 15 and the flexible longitudinal struts 16 and 17 of the armature in this embodiment , the tubular peripheral wall 23 forms the substantially continuous outer surface of the expansible sleeve 5 and the expandable casing inner armature formed by end rings 14 and 15 connected by flexible posts 16 and 17 which are themselves adapted to flex radially outwardly in this embodiment may be preferred in a continuous wall 23, a stronger material such as a reinforced polyurethane, promoting a pressure distribution on a larger surface of one bone

In the previously described embodiments, the expandable sleeve comprises a reinforcement to end ring and flexible connecting amounts may however be design, without departing from the scope of the present invention, a homogeneous expansible sleeve in which a same material is to once the end rings and the expandable tubular central portion by axial approach of the end rings, the central portion forms an annular protuberance bead

Can be found advantageous to provide further axial securing means between the corresponding ends of adjacent elements such as spacers and the expansible sleeves In this way, after loosening one nut 8, an axial traction elements hanging them to each the after another causes the axial separation of the end rings 14 and 15 and therefore the radial contraction of the expandable socket, facilitating the extraction of the intramedullary nail

For this, for example, spacers such as spacer g of Figure 4 may comprise, in the vicinity of their ends, an internal thread Similarly, the expansible sleeves such that the sleeve 3 of Figure 6 may comprise, on their rings end 14 and 15, a respective tubular extension 21 or 22 threaded and configured to be screwed into the threaded ends of the struts such that the spacer 9

In the embodiment of Figure 8, the expansible sleeve 5 comprises a ring 15 to tubular extension 22 threaded, while the ring 14 does not have such an extension, for example to only come into abutment against the head forming the axial stop 6 of the axial rod 2

It will be appreciated that, with such a structure intramedullary nail, along the rod the position of elements can be easily invert, increase the number of tubular spacers and reduce the number of expandable sleeves, or vice versa, and select the type of socket expandable depending on the channel geometry wherein the intramedullary nail 1 is intended to lock into.

The present invention is not limited to the embodiments that have been explicitly described, but includes variants and generalizations contained within the scope of the following claims

Claims

CLAIMS 1 - intramedullary nail (1) comprising:
- an axial rod (2) having, at its first end, an axial stop (6) and at its second end, a threaded portion (7) receiving a control nut (8) and having rotation locking means the axial rod (2), a plurality of adjacent elements (9, 10, 3, 4, 5) removable and interchangeable, slidably mounted on the axial rod (2) between the axial stop (bj and the actuating nut (8), at least one of said plurality of adjacent elements being an expansible sleeve (3, 4, 5) removable and interchangeable, slidably mounted on the axial rod (2) between the axial stop (6) and maneuvering nut (8),
- the expansion sleeve (3, 4, 5) comprising two end rings (14, 15) sliding on the axial shaft (2) and connected by an expandable core (16, 17, 18) adapted to deform radially towards outside during the approximation of the end rings (14, 15) towards each other under the effect of axial compression of the expansion sleeve (3, 4, 5), characterized in that the sleeve expandable (3, 4, 5) comprises a tubular peripheral wall (23) substantially continuous, flexible, expandable, biocompatible material.
2 - intramedullary nail according to claim 1, characterized in that said biocompatible material is based on polyurethane or silicone 3 - intramedullary nail according to one of claims 1 or 2, characterized in that said tubular peripheral wall (23) substantially continuous form the outer surface of the expansible sleeve (3, 4, 5) and casing an expandable inner frame formed by the end rings (14, 15) connected by flexible legs (16, 17, 18) adapted to flex radially outwardly
4 - intramedullary nail according to one of claims 1 or 2, characterized in that the expansible sleeve (3, 4, 5) comprises an expandable frame formed by the end rings (14, 15) connected by flexible struts ( 16, 17, 18) molded internally with a layer (23) of said biocompatible material forming said substantially continuous tubular peripheral wall 5 - intramedullary nail according to any one of claims 1 to 4, characterized in that said biocompatible material is armed.
6 - intramedullary nail according to any one of claims 1 to 5, characterized by:
- means (19, 20) able to block the end rings (14, 15) in axial rotation about the axial shaft (2),
- means (21, 22) of axial connection between the ends of adjacent elements correspondanteb (s, lυ, 3, 4, b), such that an axial traction on the intramedullary nail, after unscrewing the nut (8 ) causes radial contraction of the expandable or sleeves (3, 4, 5).
7 - intramedullary nail according to any one of claims 1 to 6, characterized in that: - at least one spacer (9, 10) removable and interchangeable tubular is slidably mounted on the axial rod (2) between the axial stop ( 6) and one maneuvering nut (8).
8 - intramedullary nail according to claim 7, characterized in that it comprises at least two expandable sleeves (3, 4) and a spacer (9)
9 - intramedullary nail according to any one of claims 1 to 8, characterized in that the end rings (14, 15) are connected by longitudinal struts (16, 17, 18) regularly distributed around the axial rod ( 2). 10 - intramedullary nail according to claim 6, characterized in that the end rings (14, 15) are connected by helical amounts
PCT/FR1996/001842 1995-11-21 1996-11-21 Intramedullary nail WO1997018769A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
FR9514191A FR2741256A1 (en) 1995-11-21 1995-11-21 intramedullary nail
FR95/14191 1995-11-21

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
AU7698396A AU7698396A (en) 1995-11-21 1996-11-21 Intramedullary nail

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WO2001034045A1 (en) * 1999-11-11 2001-05-17 Synthes Ag Chur Radially expandable intramedullary nail
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