DEVICE FOR INDUCING OR CORRECTING MANDIBLE GROWTH

Abstract

The present invention relates to a device for inducing or correcting mandible growth of a newborn.

The device (1) according to the invention is characterized in that it comprises: a support (100) for supporting at least one part of the rear surface of the body of the newborn, including the head, preferably in the inclined supine position, at least one extra-oral means (104, 105) for exerting a pushing force on each of the two rising branches of the mandible by means of at least one transdermal bone anchoring device (107, 108) in said branch, at least one extra-oral means (102, 103) for exerting a traction or pushing force on each of the two horizontal branches of the mandible by means of at least one transdermal bone anchoring device (106) in said branch, said extra-oral means (102, 103, 104, 105) for exerting forces being linked to the support (100) by linking means (109, 110) and to said transdermal bone anchoring devices by connection means (113, 114, 115).

Claims

1. A device (1) for inducing or correcting mandible growth of a newborn subject, characterized in that it comprises: a support (100) for supporting at least one part of the rear surface of the body of the subject, including the head, in the supine position, at least one extra-oral means (104, 105) for exerting a pushing force on each of the two rising branches of the mandible by means of at least one transdermal bone anchoring device (107, 108) in said branch, at least one extra-oral means (102, 103) for exerting a traction or pushing force on each of the two horizontal branches of the mandible by means of at least one transdermal bone anchoring device (106) in said branch, said extra-oral means (102, 103, 104, 105) for exerting forces being linked to the support (100) by linking means (109, 110) and to said transdermal bone anchoring devices by connection means (113, 114, 115).

2. The device (1) according to claim 1, characterized in that the extra-oral means (102, 103, 104, 105) are provided for exerting pushing forces.

3. The device (1) according to claim 2, characterized in that the device comprises two extra-oral means (104, 105), one (105) for exerting a pushing force on the right rising branch of the mandible by means of at least one transdermal bone anchoring device (107) in said right branch, the other (104) for exerting a pushing force on the left rising branch of the mandible by means of at least one transdermal bone anchoring device (108) in said left branch and two extra-oral means (102, 103) for exerting a pushing force on the two horizontal branches of the mandible by means of at least one, transdermal bone anchoring device (106) in the joining zone of said horizontal branches at the level of the mandibular symphysis.

4. The device (1) according to claim 2, characterized in that each of the extra-oral means (102, 103, 104, 105) for exerting pushing forces comprise one elastic means.

5. The device (1) according to claim 2, characterized in that each extra-oral means (102, 103, 104, 105) for exerting a pushing force consists of a spring actuator consisting of a cylinder (1021) fixed on the support (100) by said linking means (109, 110) and housing a rod (1026) and its piston, a compression spring being housed in the cylinder (1021) so as to apply a force suitable for causing an end (1024) of said rod (1026) provided to be connected to at least one transdermal bone anchoring device (106) to come out, a blocking means, being provided for blocking the rod (1026) in a specific position.

6. The device (1) according to claim 1, characterized in that the device comprises adjusting means (1022, 117) for adjusting the intensity and the direction of the force exerted by each extra-oral means (102, 103, 104, 105).

7. The device (1) according to claim 2, characterized in that the linking means (109, 110) between the support and the means (102, 103, 104, 105) for exerting pushing forces consist of two wings extending forward from the support and intended for flanking the head of the subject, said wings being fixed to the support on pivot pins making the wings suitable for pivoting between an open position in which the wings clear the access to the support for placing the head of the subject therein and a closed position in which the wings allow fixing the extra-oral means for exerting traction or pushing forces on the transdermal bone anchoring devices (106, 107, 108).

8. The device (1) according to claim 5, characterized in that the connection means for connecting the actuators (104, 105) to the transdermal bone anchoring devices (107, 108) at the rising branches of the mandible comprise rods (114, 115) which extend perpendicularly to the axis of the actuator cylinders and which are provided at their free ends with ball joints (1141, 1151, 1161).

9. The device (1) according to claim 5, characterized in that the connection means between the transdermal bone anchoring device or devices (106) for the anchoring thereof to the mandibular symphysis and the extra-oral means (102, 103) intended for exerting a pushing force on the horizontal branches of the mandible comprise a flexible arcuate strip (113) extending from one of the extra-oral means (102) to the other extra-oral means (103), said strip (113) having an anchoring means (116) for the anchoring thereof to the free end of said transdermal bone anchoring device or devices.

10. The device (1) according to claim 1, characterized in that the device comprises guides (119, 120, 121) for positioning and orienting the head of the subject (BB) against the support (100), such that each transdermal bone anchoring device (106, 107, 108) can be connected with the means (102, 103, 104, 105) for exerting a pushing or traction force for which it is intended.

11. The device (1) according to claim 7, characterized in that it comprises guides (119, 120, 121) for positioning and orienting the head of the subject (BB) against the support (100) and between said wings (109, 110), such that each transdermal bone anchoring device (106, 107, 108) can be connected with the connection means (113, 114, 115, 116) for which it is intended, the guides consisting of two rods (119, 120), each one assembled on a wing (109, 110) and made suitable for sliding with respect to that wing when in the closed position until the end of the rod slightly enters the auditory canal of the subject (BB), and of a third rod (121) suitable for sliding with respect to the support (100) from the top end of that support until the end of the rod (121) abuts against the apex of the head of the subject (BB).

12. The device (1) according to claim 1, characterized in that said support (100) is in the shape of a bassinet, a cradle, a bed or a baby rocker, consisting of a surface for resting the whole rear surface of the subject (BB).

13. The device (1) according to claim 2, characterized in that the device comprises two extra-oral means (104, 105), one (105) for exerting a pushing force on the right rising branch of the mandible by means of at least one transdermal bone anchoring device (107) in said right branch, the other (104) for exerting a pushing force on the left rising branch of the mandible by means of at least one transdermal bone anchoring device (108) in said left branch and two extra-oral means (102, 103) for exerting a pushing force on the two horizontal branches of the mandible by means of one transdermal bone anchoring device (106) in the joining zone of said horizontal branches at the level of the mandibular symphysis.

14. The device (1) according to claim 4, characterized in that each of the extra-oral means (102, 103, 104, 105) for exerting pushing forces comprise a spring actuator.

15. The device (1) according to claim 4, characterized in that each of the extra-oral means (102, 103, 104, 105) for exerting pushing forces comprise-a gas actuator.

16. The device (1) according to claim 2, characterized in that each extra-oral means (102, 103, 104, 105) for exerting a pushing force consists of a spring actuator consisting of a cylinder (1021) fixed on the support (100) by said linking means (109, 110) and housing a rod (1026) and its piston, a compression spring being housed in the cylinder (1021) so as to apply a force suitable for causing an end (1024) of said rod (1026) provided to be connected to at least one transdermal bone anchoring device (106) to come out, a blocking means, the blocking means being a screw (1029) passing through the wall of the cylinder (1021), being provided for blocking the rod (1026) in a specific position.

Description

[0045] The features of the invention mentioned hereinabove, as well as others, will become more evident after reading the following description of an exemplary embodiment, said description being made in relation to the attached drawings, in which:

[0046] FIG. 1 shows an overview of a device according to the invention according to one embodiment of the invention, in which the subject to be treated is placed,

[0047] FIG. 2 shows a perspective view of a portion of a device according to one embodiment of the invention, in which the subject to be treated is not placed,

[0048] FIG. 3 shows a perspective view of a portion of a device according to one embodiment of the invention, in which the subject to be treated is placed,

[0049] FIG. 4 shows a side profile view of a portion of a device according to one embodiment of the invention, in which the subject to be treated is not placed.

[0050] FIG. 1 shows an overview of a device 1 according to the invention in which a subject BB, such as a few weeks old infant, has been placed to be treated therein. The device 1 comprises a support 100 in the shape of a baby rocker on which the subject BB is placed laying on his/her back, preferably in an inclined position. Preferably, the subject BB is inclined according to an angle of about 30° with the ground. Since the device is essentially provided for an infant, the support 100 will be designed for allowing an extended position for the baby in all cases on his/her back. One part of the support 100 has an accommodation 101 for receiving the rear surface of the head of BB and participate in his/her comfort. It can be, for example, a pillow attached to the support 100. A holding strap 130 is optionally provided for ensuring that the subject BB is held extended on the support 100.

[0051] FIG. 2 shows the device 1 in the absence of the subject BB. The device 1 is symmetrical on both sides of its vertical central axis Av.

[0052] The device 1 comprises four extra-oral means 102, 103, 104 and 105 for exerting pushing forces on the four mandibular branches, respectively, by means of transdermal bone anchoring devices, such as osteointegrated transcutaneous implants 106, 107, 108.

[0053] The extra-oral means 102, 103, 104 and 105 for exerting forces on the mandible are outside the oral cavity of the subject when he/she is being treated (FIG. 3). In currently used mandibular distraction devices, the bone is placed under stress by means of a distractor inside the oral cavity and even the bone cavity. The extra-oral means 102, 103, 104, 105 are linked to the support 100 by linking means 109, 110 described below.

[0054] The transdermal implants 106, 107, 108 are represented in FIG. 2 connected to the device 1, but they are in fact implanted by means of surgery in the branches of the mandible before placing the subject BB on the device 1, and before treating him/her. The implant 106 is at the level of the axis of symmetry Av of the device 1 and is intended for being osteointegrated at the level of the mandibular symphysis, the zone of convergence of the horizontal branches of the mandible. The implant 107 is to the left of the axis of symmetry Av and is intended for being osteofixed in the left rising branch of the mandible. The implant 108 is to the right of the axis of symmetry Av and is intended for being osteofixed in the right rising branch of the mandible.

[0055] The extra-oral means 104 and 105 are intended for exerting pushing forces on the left and right rising branches, respectively, of the mandible of the subject. The extra-oral means 102 and 103 are intended for exerting pushing forces on the left and right horizontal branches, respectively, of the mandible of the subject. As a consequence, the extra-oral means 102 and 104 are arranged to the left of the axis of symmetry Av of the device and the extra-oral means 103 and 105 are arranged to the right of the axis of symmetry Av of the device 1. As for the subject BB, he/she is to be placed on the central axis Av of the device 1 as can be seen in FIG. 1.

[0056] The pushing forces on the branches of the mandible are exerted from the device 1 since the extra-oral means rest thereon and not on the subject to be treated. For example, the forces can be supported from the support 100 at the back of the head. The principle of treatment consists of defining a trajectory in space which each point of the transdermal implant 106, 107, 108 must follow in order to obtain a growth which remodels the mandible. The operating dimensions are calculated from a reference point located on the device. In addition to its function as an ergonomic guide for the child placing him/her in the best possible position, the support 100 has the function of ensuring the starting point (point “zero”) of the chain of the operating dimensions of the device. It shows the kinematic and mechanical reference of the device. The ensemble of the elements, specifically of the extra-oral means, can be adjusted in function and in dimension from that point. To that end, the extra-oral means 102, 103, 104 and 105 are linked to the support 100 by linking means. In the preferred embodiment of the invention and as depicted in FIGS. 1 to 3, the linking means consist of a pair of wings, or leaves, 109, 110 assembled on the support 100 on pivot pins 111, 112, respectively, on both sides of the axis of symmetry Av. The pivot pins can be established by means of hooks, hinges, pin hinges or any other means known to the person skilled in the art.

[0057] The wing 109 supports the extra-oral means 102 for exerting a pushing force on the left horizontal branch of the mandible of the subject BB as well as the extra-oral means 104 for exerting a pushing force on the left rising branch (FIGS. 1 and 3). The wing 110 supports the extra-oral means 103 for exerting a pushing force on the right horizontal branch of the mandible of the subject BB as well as the extra-oral means 105 for exerting a pushing force on the right rising branch (FIGS. 1 and 3).

[0058] The wings 109, 110 are provided for flanking the head of the subject BB. In addition, they are provided for pivoting between a so-called open position in which they clear the access to the support 100, particularly for placing the head of the subject BB therein, and a so-called closed position in which they allow connecting the extra-oral means 102, 103, 104, 105 to the transdermal implants 106, 107, 108.

[0059] Therefore, the device 1 comprises two symmetrical, side mechanical parts which can be retracted by tilting and each of which includes two independent means ensuring a specific pushing on the horizontal and rising branches, respectively.

[0060] The extra-oral means 102 for exerting a pushing force is shown in detail in FIG. 4. It consists of a cylinder 1021 which is fixed to the wing 109 on a rotation shaft 1022 by means of a flange 1023. Inside the cylinder 1021 a rod 1026 and its piston (not shown) can slide freely (FIG. 4). An end 1024 of the rod comes out at the end 1025 of the cylinder 1021. This end 1025 is provided with a connection means 113 for the connection thereof with the implant 106. A compression spring is housed inside the cylinder 1021 so as to apply a force suitable for causing the end of the rod 1024 to come out at the end 1025 of the cylinder 1021. A blocking means 1029, such as a screw passing through the wall of the cylinder 1021, is used for blocking the rod 1026 in a chosen position. A nut 1027 is screwed on the part of the rod 1026 which comes out at the other end 1028 of the cylinder. This nut 1027 acts as a stop to the advancement of the end 1024 of the rod which must be connected to the implant 106.

[0061] The pushing means 102 are preferably a spring actuator, since a spring with a specific stiffness suitable for the application can be chosen. In practice, mandible growth is less than 2 cm. Depending on the chosen spring, an almost constant pushing force can be obtained. However, in a variant of the invention, a gas actuator can be absolutely suitable.

[0062] The previous description in relation to the extra-oral means 102 applies to the extra-oral means 103, 104 and 105 since they are preferably identical to the means 102.

[0063] The connection means for connecting the actuators 104 and 105 to the transdermal implants 107 and 108, respectively, include rods 114 and 115 which extend from the ends 1044 and 1054 of the actuators and perpendicularly to the axis of those actuators and are provided at their free ends with ball joints 1141, 1151 (FIG. 2, FIG. 3). The ball joints allow for the connection between the implants and the actuators. Indeed, while placing the implants in the mandible, they may not be implanted exactly at the expected site. Consequently, the ball joint allows correcting the separation distance between the expected implantation site and the actual implantation site.

[0064] The connection means for connecting the actuators 102 and 103 to the transdermal implant 106 include a flexible arcuate strip 113. It extends from the actuator 102 to the actuator 103 and is placed facing the chin of the subject BB when he/she is placed on the support 100 (FIG. 3). The flexibility is required to allow small mandible suction movements for the subject. A rod 116 is also provided. One of its ends is linked to the implant 106 by means of a ball joint 1161 and its other end is housed in a housing 118 performed in the arcuate strip 113. This rod 116 remains preferably connected to the implant 106 such that an offset is arranged in the housing 118 so as to insert the end of the rod 116 in that offset and is then caused to slide in a narrower zone of the housing for the blocking thereof.

[0065] The pushing forces are exerted on the branches of the mandible so as to obtain mandible growth in three dimensions. Generally, the force exerted on each rising branch will be directed forwards and downwards. The force exerted on each horizontal branch will be exerted forwards.

[0066] The directions of the pushing forces exerted by each extra-oral means 102, 103, 104, 105 can be adjusted by adjusting means. The adjusting means include, specifically, adjusting means for adjusting the position of the axes of the springs of the actuators 102 to 105 in space. For example, concerning the actuator 102, the adjusting means include the rotation shaft 1022 on which the cylinder is fixed on the wing 109. Thanks to this rotation shaft 1022, the axis of the spring can be moved by rotation in a plane parallel to that of the wing 109 (arrow R, FIG. 4). This plane is also substantially parallel to the side face of the branch of the mandible on which the pushing force must be exerted. Therefore, the adjusting means allow the orientation of the axis of the spring of each actuator with respect to the branch of the mandible on which that spring must exert a pushing force.

[0067] The adjusting means also include a slot 117 made in the wing 109 and in which the rotation shaft 1022 can be moved (arrow T, FIG. 4), in a plane parallel to that of the wing 109. This plane is also substantially parallel to the side face of the branch of the mandible on which the pushing force must be exerted. These adjusting means also allow adapting the device to the morphology of the subject so as to allow the connection with the osteointegrated implants. Identical adjusting means are provided with respect to the actuators 103, 104 and 105.

[0068] The intensity and direction of the force exerted by each of the actuators are determined and adjusted at the beginning of each treatment for each subject. Therefore, when the subject is removed from the device 1 for the purpose of changing or feeding, and then placed therein again, the forces which are applied anew on the mandible are identical to those that were applied before he/she was removed from the device.

[0069] When placing the subject BB, the wings 109 and 110 are placed in an open position and therefore each of them pivots in a direction opposite the axis Av. The head of the subject BB is placed against the housing 101 of the support 100. The subject is in an extended position on his/her back against the support 100 (FIG. 1). The wings 109 and 110 are tilted by pivoting in an inverse direction into a so-called closed position in which they flank the head. p In order to correctly place the free ends of the transdermal implants 106, 107, 108 facing the connection means 114, 115, 116 for the connection thereof to the actuators 102, 103, 104, 105, the device 1 comprises guides for positioning and orienting the head of the subject BB against the support 100 and between the wings 109 and 110. These guides consist of two rods 119, 120, respectively assembled on the wings 109 and 110 and suitable for sliding with respect to these wings when they are in the so-called closed position until the end of each rod slightly enters the auditory canal of an ear of the subject (FIG. 3). In addition, a third rod 121 is provided. It is suitable for sliding with respect to the support 100 from the top of the support until the end of the rod 121 abuts against the apex of the head of the subject where a target M in the shape of a mark or tattoo is drawn. Finally, the ball joints 1141, 1151, 1161 also allow for the connection of the transdermal implants 106, 107, 108 which are connected to the means 102, 103, 104, 105.

[0070] Once the subject is placed, the transdermal implants 106, 107, 108 are connected to the means 102, 103, 104, 105 exerting the forces via the connection means described above. The rods 119, 120, 121 are moved so as not be in contact with the subject.

[0071] As mentioned above, the absence of any anchoring to the maxilla can be noted, although such an anchoring could be considered depending on the malformation or pathology to be treated. In such case, means for exerting forces on the maxilla would be identical to those described in relation to the mandible (102, 103, 104, 105).

[0072] The placing of the subject and the removing thereof are simple and they are performed as many times needed depending on the typical daily care of the subject, such as breastfeeding, bathing and cuddling.