WO2006010844A1

WO2006010844A1 - Device for self-correction of scoliosis not requiring interventions after implantation

Info

Publication number: WO2006010844A1
Application number: PCT/FR2005/001624
Authority: WO
Inventors: Frédéric Fortin; Johann Robin; Jérôme SALES DE GAUZY
Original assignee: Fortin Frederic; Johann Robin; Sales De Gauzy Jerome
Priority date: 2004-06-29
Filing date: 2005-06-28
Publication date: 2006-02-02
Also published as: FR2872021A1; FR2872020A1; FR2872020B1; FR2872021B3

Abstract

The invention concerns a device (1) for self-correction of scoliosis (1) consisting of assemblies of means (2), (3), (4) and (5), the subassembly of means (2) consisting: of a rod (21) hooked to the ends of the concavity of the scoliosis by two fixing elements (22 and 23); an assembly of means (3) comprising two rods (31 and 32) hooked to the spine by other catching means (33 and 34) located at the ends of the chord D of the arc defined by the curvature of R of the scoliosis, the rods (31 and 32) capable of freely sliding through orifices located at the ends of a U-shaped part (4) wide open to enable said rods to be optimally guided, the part (4) itself consisting of a rod (41) comprising on its body identical indentations adapted to receive set screws, enabling a link to be provided between the subassemblies (2) and (3) via a part (5) as well as for a minimally adjusted setting of the device (1), having preferably the shape of a small single-piece tile allowing the passage of the rods (21 and 41).

Description

SCOLIOTIC AUTOCORRECTION DEVICE REQUIRING MORE INTERVENTIONS AFTER IMPLANTATION

Field of the Invention: The present invention relates to a device for self-correcting a scoliosis, which once placed on the spine of a child no longer requires interventions.

PRIOR ART US Pat. No. 5,261,908 relates to an expandable intervertebral prosthesis which is fixed on the ribs of the patient and which thus makes it possible to prevent scoliosis from worsening, this invention could not reduce scoliosis, it adapts to certain vertebral pathologies for which it is difficult or impossible to focus on the vertebrae, the means used and the problem to be solved are different.

The Fortin patent entitled: Distraction device for children's bones having attachment and adjustment means for monitoring their growth filed in France under No. 9907034 does not solve the same problems, this device clings also rather on the coasts and require interventions to follow the growth of the rachis.

The present invention solves the problem of correcting scoliosis without fusion and without any other intervention than the implantation of the present device. In addition, the means used to obtain the desired effects are different from those found in the two aforementioned patents of the prior art.

The present invention, thanks to the new means implemented will correct the scoliosis at a young age, without re-intervention of the operator, moreover its design gives it an easy implementation in a minimum of space. The drawings used for understanding the invention are: Figurel plate 1/11 overview of a first variant device assembled without rings

Figure 2 plate 1/11 overview of the assembled device with anti-return rings

Figure 3 plate 2/11 overview of the device on a spine

Figure 4 plate 3/11 view of a connecting piece connecting the two essential subsets of the device

Figure 5 plate 3/11 connecting piece seen in the sagittal plane with arched stems

Figure 6 plate 3/11 perspective view of a connection connector with its sliding and gripping holes Figures 7a, 8a, 9a plate 4/11 Three diagrams showing the

Dynamics of recovery.

Figures 7b, 8b, 9b plate 5/11 Evolution of the geometrical parameters corresponding to the previous figures of plate 4/11 (Dynamique de redressement) Figures 10 and 1 1 plate 6/11 second variant of the device

Figure 10 perspective view of another version improving the first device

Figure 11 sectional view of this same new device Figure 12 board 7/11 exploded view of the means forming this new device that perfects the first

Figures 13, 14, 15, and 16 plate 8/11 overview in perspective showing the various phases of its assemblies and adjustment during its installation Figure 17 plate 9/11 perspective view of the same device with no connection by ring. Figures 18 Plate 9/11 perspective view of the device (version 2) with all of its means with hooking by link which slides through a central tube

Figures 19, 20, and 21 plate 10/11 three perspective views of the device corresponding to phases of adjustments of the central rod during installation

Figure 2Od plank 10/11 detail of the sectional view of the cross-sectional rod with adjustable distance the longitudinal tube that follows the growth

Figures 22,23,24,25,26,27 and 28 Plate 11/11: perspective views of a set of means or small elements forming part of the version 2 device.

The definition of self-correction of the described and claimed device (s) arises from the fact that the growth of the child is used to reduce scoliosis.

They adapt to all the deformities during its installation They correct the scoliosis by the growth of the child, and are constituted of extremely simple means compatible with the environment of the human body and resistant.

We will now describe each of the devices by explaining the functionality of the means, in two preferred embodiments whose general design mode is explained on page 9 of this description.

In a first embodiment corresponding to a first version of the self-correction device, the device 1 consists of a set of means 2,3,4 and 5 (FIG. 1) formed of subassemblies whose means functionally combine to reduce scoliosis.

The subset of means 2 consists of a rod 21 two fastening means 22 and 23 of the rod 21 on the spine (hooks or screws), these clipping means being fixed at the top of the concavity of the curvature to be corrected

The set of means 3 comprises two rods 31 and 32 attached to the spine by means 33 and 34 at the ends of the rope D of the arc defined by the curvature.

These clipping means 33 and 34 may be: hooks pedicle screws or stirrups hanging on the ribs.

These rods 31 and 32 can freely slide through the orifices 43 (a and b) and 44 (a and b) located at the ends of a part 4 which preferably has the shape of a U open to allow optimal guiding . This piece 4 could also be of parallelepipedal shape such as a small block, with orifices 43 (a and b) and 44 (a and b).

The part 4 is composed of a rod 41 having on its body identical impressions 42 a, b, c. .. which can receive for example needle screws, to ensure a connection between the subassembly 2 and the subassembly 3 this via a part 5.

The part 5 still called subassembly 5 is preferably a small block (FIG. 6) of suitable shape, it may also be a hook. The part 5 comprises: two holes 51 and 52 allowing the passage perpendicularly of the rods 21 and 41

They also include two means such as notches 53 and 54 holes for gripping with a surgical tool.

It also has a tapping 55 to receive a needle screw which will be placed in one of the conical notches 42 (a, b, c ..) this to ensure a rigid connection between all means 2 and 3 to increase as much as possible at the time of implantation the Ray R of scoliosis by minimizing the distance f between the maximum curvature and the middle of the rectilinear part of the part 4 (minimum distance targeted during the implantation of the device)

The entire device 1 is connectable to the spine or ribs by the subassembly 3 which is constituted by fastening means such as for example: stirrups, hooks or pedicle screws The self-correction device 1 through the combination of the all of the means previously described have a certain number of mechanical characteristics which ensure the self-correction only by the growth, knowing that certain geometrical parameters are fundamental:

Distance D between the clipping devices 33 and 34 is extensible, this distance increasing in D1 D2 D3 (Figures 7b, 8b, 9b) with growth.

Arrow f between the curvature and a catch 45 located in the middle of the rectilinear part of the U-shaped piece 4, k being a constant value with f = k by construction of the device 1 radius R of scoliosis curvature, which value increases with growth.

Under the action of the growth of the child, D increases (in D1, D2, D3) because the rods 31 and 32 are attached to the vertebrae or the ribs and that said rods 31 and 32 can freely slide in the room 4.

The growth of the child leads, because of the constancy of f, an increase in the radius of curvature R scoliosis, ie a recovery that tends to transform the curvature in a straight line, this thanks to the mechanical characteristics chosen the construction of this self-correction device, which needs no intervention, except a follow-up by medical imaging. Other essential characteristics of the invention are the following:

The rods 31 and 32 slide in the holes (43a and b) and (44a and b) with a clearance allowing good sliding even for curved rods while maintaining good rigidity to the device 1

The manufacturing material used has good ductility with elasticity adapted to the forces exerted which are discontinuous and non-linear, it must allow without breaking the bending of the rods 31 and 32,. It must of course be biocompatible

The part 4 accepts to receive slightly curved sliding rods by virtue of the preceding characteristics of the selected material or materials, the surface conditions and the games are determined with precision, moreover no salient profile is accepted, so that the device 1 avoids injure the surrounding tissues.

On each of the rods 31 and 32 can be implanted according to the pathologies of the "anti-return" rings 310 and 320 located on the side of the fixing of the rod 31 or 32 and resting on one of the outer face of the end. U of the room 4 (figure 2)

Their function is to maintain a sufficient tension between the attachments 33 and 34 located at each end of the rods 31 and 32, increasing the distance D, thus avoiding a return to the initial state, before the growth effect does not take over. In a second embodiment, the self-correction device 10 comprises:

a preferably cylindrical tube 11 having a solid portion in the center and in which the two identical symmetrical rods 12 connected to the hooks 33 and 34 are free to slide in the hollow portions and which have guide and stop means of start and end of race, namely:

guide means of the rod 12 in the tube 11 which are: at the inlet of the tube a bearing 122 which guides the rod in the tube at the end of the rod 12, a piston 121 which slides inside the tube 11

- end stop means the stroke of the rod 12 in both directions and which are on one side the stop 110 and on the side of the maximum elongation the bearings 120 on which the piston 121 comes to lock

at least one vent 110 which avoids a compression of the air or gas which will enter the tube 11 and which could block the rods

a pivot pin 13 able to translate and pivot freely around the tube 11,

This pivot rod 13 comprises a cylindrical ring 130 encircling the tube which can also itself translate and rotate around the tube 11.

This ring 130 is connected to a rod 31 or which is part of it, it may be fluted threaded or have notches allowing a connection between the means 6 (screw) and the tube 11.

During the introduction of the device 10, the pivot rod 13 is placed in the housing 64 (Figure 14) of the head of the fastening screw on a vertebra of the spine (middle 6) in which it can translate before fixation, this which allows the operator to minimize the arrow f (as in the first embodiment) by bringing the attachment 6 as close as possible to the tube 11, which is then blocked by tightening a threaded plug 61. Compared in the first embodiment, this second embodiment further reduces the arrow f at the time of installation of the device. After placing and tightening the means 6, the protruding, useless, or even annoying portion of the rod 31 is severed. Another embodiment of this attachment (FIG. 17) thus consists of the means 5 (of the first embodiment): a small block (FIG. 6) associated with the pivot rod 13 with the means 2 and comprising the rod 21 carrying at its end two hooks 22 and 23 In this second embodiment, part 4 of the first embodiment is thus replaced by a set of means.

7 comprising a pivot rod 13 and a tube 11 combined with a ring

130 which will allow the sliding of the rods 12 along the axis of the elongation.

In another illustrative example of this embodiment, the pivot rod 13 is replaced by a connecting rod 14 which translates transversely through the solid portion of the tube 11 which can be determined the location of the attachment with a maximum of traction and then we will block at this location with a screw 15, which will keep constant the arrow f.

The connection of the tube 11 with the means 2 is provided by a ring 141 connected to the rod 14 or which is part thereof and which receives the rod 21 carrying fastening means attached to the vertebrae of the spine. In this embodiment, it is possible to add a reinforcement 8 (FIG. 28) positioned on the tube 11 longitudinally at its center (FIG. 18) and to block the rod 14 by tightening a screw 81 which is applied to this rod, allowing thus to ensure optimum mechanical strength.

The implementation phases are as follows: 1- Placement on the vertebrae or on the bones concerned of the attachment means 22, 23, 6, 33, 34.

2- Placement of the tube 11 receiving the two sliding rods 12 with means 13 or 14

4- Attaching the ends of the rods 12 with the clipping means

5-Maximum approximation means 6 or 2 to the tube 11 so that the arrow f is as low as possible to achieve the best possible correction of scoliosis curvature.

6-Sectioning the protruding portion of the connecting rod 13,14, to ensure the locking of the residual arrow f The most essential feature of this invention is that it has lengthening means attached to the bones to guide growth in a straight line, said means being combined with traction means hooked to the top of the concavity of the curvature spine and which exert traction on it to cause its recovery during this growth, these features are obtained by devices 1 and 10 given by way of example. The elongation means of the devices 1 and 10 are for example rods 31, 32 or 12 being slidable in sets of means 4 or 7; the rods 31, 32 or 12 being attached to the bones by hooking means 33 and 34.

The attachment means at the top of the curvature of the spine 2 or 6 are for example a rod 21 attached to the vertebrae of the spine by clashes 22 and 23, the rod 21 being connected.

on the one hand by a transversal connection 41 or 13 to all the means of extension of the device 4 or 7

on the other hand at the midpoint of the rod 21 by an adjustable fastening means 5 or 6

The means of attachment to the spine are connected by a set of means 4 or 7, the essential means of connection being the shaft 41 or 14, which is fixed to the mounting the length of attachment to the vertebrae of the spine by tightening screws or screw plug 15 or 61, this to optimize a minimum distance or a residual arrow of scoliosis.

This arrow will remain constant during the elongation, which will allow an increase in the radius R (FIGS. 7a, 8b, 9b) during the growth, the latter causing the sliding of the rods 31, 32 or 12 which will generate self-redirection by traction at the point of maximum curvature of the spine. (see Figures 7a 8a 9a). After installation of one of these devices 1 or 10, there is no more intervention on the patient

In all these devices, whatever the embodiment, the set of parts allows a very easy implementation of both the elements manufactured and their assembly performed outside intervention or during the latter

R E V E N D I C A T IO N S

1-scoliotic self-correction devices (1) and (10) characterized in that they comprise: - elongation means which are for example rods

(31, 32 or 12) sliding in sets of means (4) or

(7), the rods (31,32) or (12) being fixed to the bones by hooking means (33 and 34) -means of attachment to the vertex of the curvature of the spine (2 or 6) as per example a rod (21) attached to the vertebrae of the spine by snaps (22 and 23), the rod 21 itself being connected. on the one hand, by a transverse connection means (41 or 13 or 14) to all of the means for extending the device (4 or

7) and on the other hand, at its midpoint by an adjustable hooking means (5 or 6), the spinal attachment means being connected by a set of means (4 or 7), said connecting means ( 41, 13 or 14), which can be adjusted in length between its attachment to the vertebrae of the spine and its attachment point (45) on one of the means: part (4, 13 or 14), by clamping using of a screw or a screw plug (15 or 61), at a determined clamping point, to optimize a minimum distance or a residual arrow (f) of the scoliosis, which remains constant during the elongation, this combination of means will allow an increase in the radius (R) of the curvature of the scoliosis during growth, driven by the possible sliding of the rods (31, 32 or 12) which lengthen during the growth, and which are thus generate traction self-straightening at the point of maximum curvature of the spine.

Claims

2-Device 1 for the self-correction of a scoliosis (1) according to claim 1 characterized in that it consists of sets of means (2), (3), (4) and (5) the subset of medium 2 consisting of: -a rod (21) attached to the ends of the scoliosis concavity by two fasteners (22, and 23)

a set of means (3) comprising two rods (31 and 32) attached to the spine by other attachment means (33 and 34) located at the ends of the rope D of the arc defined by the curvature R scoliosis, the rods (31 and 32) being freely sliding through orifices (43 a and b) and (44 a and b) located at the ends of a piece (4) which preferably has the shape of a U widely open to allow optimal guidance of said rods, the part (4) being itself composed of a rod (41) having on its body identical impressions (42 a, b, c.) can receive screws needle, providing a connection between the subassemblies (2) and (3) via a workpiece (5) and a minimum setting of the device (1), cettedi the piece (5) having preferably the shape of a small block monobloc ensuring the connection of the rods (21 and 41) which can however slide, this combination of fixed and sliding means for auguring to bring the radius R curvature of scoliosis by the sole effect of growth and no longer requiring intervention once the device (1) posed 3-device 1 for self-correction of a scoliosis (1) according to claim 2 characterized in that the part (5) comprises: two bores (51 and 52) allowing the passage of two and three rods (21 and 41) in a perpendicular manner such as notches, bores (53 and 54) for gripping with a surgical tool,

a tapping (55) for receiving a needle screw which will be placed in one of the conical notches 42 (a, b, c ..) this is to ensure a rigid connection between all the means

(2 and 3) to increase as much as possible at the time of implantation the Ray (R) of scoliosis by minimizing the distance (f) between the maximum curvature and the hooking (45) located at the midpoint of the part rectilinear of the room (4)

4-device (1) of autocorrection a scoliosis (1) according to claims 1 and 2 characterized in that said device (1) has the following properties: distance (D) between clashes for example (33 and 34) is self-expanding, arrow (f) between the scoliotic curvature apex and the hook (45) in the middle of the rectilinear portion of the U-shaped workpiece (4) is constant, which allows the spoke (R) to increase as the distance (D) increases

5-device (1) for self-correction of scoliosis (1) according to claims 1, 2 and 3 characterized in that the rods (31 and 32) slide in the orifices (43a and b) and (44a and b) ) with a clearance allowing a good sliding even for arched rods while maintaining a good rigidity to the device (1)

6 -Dispositif (1) self-correction of a scoliosis (1) according to claims 1, 2, 3 and 4 characterized in that on the rods (31 and 32) can be implanted, anti-return rings (310 and 320) located on the side of the fixing of the rod (31 or 32) and resting on one of the outer face of the U-shaped end of the part (4), their function being to maintain a tension between the fasteners of the spine (33 and 34) located at each end of the rods (31 or 32) by increasing the distance D and thus avoiding a return to the initial state before the growth effect takes over 7- self-correction device 10 according to claim 1 characterized in that it comprises:

a preferably cylindrical tube (11) having in its center a solid part and in which the two hollow rods (2) symmetrically connected to the hooks (33 and 34) slide freely in the hollow portions and which have guide means and stop of start and end of race, namely:

means for guiding the rod (12) in the tube (11) which are at the inlet of the tube a bearing (122) which guides the rod in the tube and at the end of the rod (12) a piston (121) sliding inside the tube (11)

- end stop means the stroke of the rod (12) in both directions and which are on one side the stop (110) and on the side of the maximum elongation the bearings (120) on which the piston (121) ) comes to hang.

at least one vent (110) which avoids a compression of air or gas which will enter the tube (11) and which could block the rods; a pivot rod (13) able to translate and pivot freely around the tube; (11)

8-self-correction device 10 according to claim 7 characterized in that the pivot rod (13) comprises a ring (130) cylindrical encircling the tube which can translate and rotate around the tube (1 L), the ring (130) being connected to a rod (13) or part thereof, it may be fluted thread or have notches allowing a connection between the means 6 (screw) and the tube (11.)

9- self-correction device 10 according to claim 8 characterized in that the pivot rod 13 is placed in the housing (64) of the head of the screw (6) of attachment to a vertebra of the spine in which it can translate before fixation , which allows the operator to minimize the arrow (f) as in the first embodiment) by bringing the fixing (6) the most possible tube (11), which is then blocked by tightening a screw cap (61)

10- self-correction device (10) according to claim 9 characterized in that the fastening means on the rod (14) may consist of the means (5) which is a small block associated with the pivot rod (13) with the medium (2), comprising the rod (21) carrying at its end two hooks (22 and 23)

11-self-correction device 10 according to claims 2 and 7 characterized the piece (4) can be replaced by a set of means (7) comprising a pivot rod (13) and a tube (11) combined with a ring (130) which will allow the sliding of the rods (12) along the axis of the elongation that follows the growth

12-self-correction device 10 according to claim 11 characterized in that the pivot rod (13) is replaced by a connecting rod (14) which translates transversely through the solid part of the tube (11) which can be determined by location of the attachment with maximum traction and then we will block at this location with a screw (15) which allows to keep constant the arrow (f)

13-self-correction device 10 according to claim 12 characterized in that the connection of the tube (11) with the means (2) is provided by a ring (141) connected to the rod (14) or which is part thereof and receives the rod (21) carrying attachment means attached to the vertebrae of the spine.

14-self-correction device 10 according to claim 7 and 11 characterized in that may add a reinforcement (8) positioned on the tube (11) longitudinally at its center and block the rod (14) by tightening a screw (81). ) applying on this rod, which ensures an optimum mechanical strength.