WO2018220242A1

WO2018220242A1 - Otoplasty implant reloading device

Info

Publication number: WO2018220242A1
Application number: PCT/ES2017/070380
Authority: WO
Inventors: Arturo RUIZ CASADO
Original assignee: Tt Innovation Healtools, S.L.
Priority date: 2017-05-31
Filing date: 2017-05-31
Publication date: 2018-12-06

Abstract

The present invention discloses a device providing easy reloading of otoplasty implants. The device object of the present invention comprises: a channel (30) for receiving an implant deployment gun having a horseshoe shaped implant (2) with the distal end thereof attached to said gun; means (31) for fastening the gun; a flattening element (320) arranged over the channel; and a pressing element (33). The flattening element is preferably arranged between the two ends of the implant and comprises longitudinal displacement means along the channel so as to deform the implant, and the pressing element presses the distal end of the implant into the gun.

Description

OTOPLASTIA IMPLANT RECHARGE DEVICE

D E S C R I P C I O N OBJECT OF THE INVENTION

The present invention relates to a recharge device for otoplasty implants intended to surgically correct deformities in patients, namely, prominent ears.

BACKGROUND OF THE INVENTION

There are currently implant applicators for otoplasty that are basically a pre-filled gun with an implant. The implant is an elastic, preferably metallic, horseshoe-shaped sheet that, during the preload procedure, is stretched so that it is flat on the tip of the gun. Subsequently, the surgeon through a surgical procedure inserts the tip of the gun into the ear and pulls the trigger, the implant is released from the gun and recovers its original horseshoe shape inside the ear, modifying the shape of the auditory pavilion.

In plastic surgery operations for correction of prominent ears, it is common for the surgeon to place an implant, and if you do not get the desired result, remove it and look for a new position to reimplant. The implant placement system of the technique, as mentioned above, consists of a factory pre-loaded gun with an implant at the tip of the gun, that is, said gun is for single use only and has no means of recharging an implant already fired and returned to its shape, for example, horseshoe or means for the placement of a new implant, so the surgeon is forced to use a new applicator-implant assembly, which generates higher costs and waste of medical equipment.

Therefore, the main drawback of this system is that the gun does not have an implant recharge mechanism once fired, that is, once it has elastically recovered its horseshoe shape. The present invention discloses a refill device for said otoplasty implants. DESCRIPTION OF THE INVENTION

In order to solve the problems of the prior art, the present invention discloses an otoplasty implant recharge device of the type comprising:

· A channel for receiving an implant placement gun with a horseshoe-shaped implant with its proximal end attached to said gun;

• means of attachment to the gun;

• a flattening element arranged on the channel; Y

• a pressure element;

wherein the flattening element is disposed between the two ends of the implant and comprises means of longitudinal displacement along the channel to deform the implant and the pressure element presses the distal end of the implant to the gun.

Preferably, the pressure element is connected to a fixed body comprising the channel and the flattening element is connected to a mobile body.

Additionally, the pressure element can be connected with rotation capacity to the fixed body. In addition, the pressure element may have an arcuate surface in contact with the movable surface, so that the rotation of the pressure element causes a longitudinal movement of the flattening element.

In a particular embodiment, the recharging device has guiding means for the displacement of the flattening element. Preferably, the gun clamping means are pressure clamping means. Said means for holding the gun can comprise, for example, a clamp.

In a particularly preferred embodiment, the flattening element is suitable for deforming metal implants.

As for the manufacturing materials, the recharging device may be made of at least 85% plastic, preferably at least 95% plastic. Additionally, the recharging device may comprise a maximum of 10% stainless steel, preferably a maximum of 5%. Alternatively, it could be manufactured entirely in metal with stainless properties, for example stainless steel, in which case the mechanism would be non-disposable and should become sterilized material between interventions. DESCRIPTION OF THE DRAWINGS

To complement the description that is being made and in order to help a better understanding of the characteristics of the invention, according to a preferred example of practical implementation thereof, a set of drawings is attached as an integral part of said description. where, for illustrative and non-limiting purposes, the following has been represented:

Figure 1 shows a gun for surgical application of an otoplasty implant of the type to be recharged with a device according to the present invention.

Figure 2 shows a longitudinal section of a recharging device according to the present invention. Figure 3 shows a perspective view of a gun arranged to be reloaded with an implant with the device being in an initial position.

Figure 4 shows a cross-sectional view of a gun being recharged by a device according to the present invention with the device being in an intermediate position.

Figure 5 shows a cross-sectional view of a gun being recharged by a device according to the present invention, the device being in a final position.

PREFERRED EMBODIMENT OF THE INVENTION

In order to insert the implant surgically into the patient's ear, the implant must be inserted while it is flattened so that the incision necessary to perform the procedure can be reduced. Consequently, Figure 1 shows a gun 1 for surgical insertion of an implant 2, in particular an elastic implant which, when released, has a horseshoe shape. The gun comprises an applicator 10, a holding handle 1 1 and a trigger 12. For use, the user makes an incision in the patient's ear with a size sufficient to insert the applicator 10.

Once the incision is made, the applicator 10 is inserted along with the implant 2 through said incision. The applicator is moved to a predefined position and represents the place where the defect of prominent ears is aesthetically corrected if a flexion is made in a direction substantially towards the patient's head. When the applicator 10 is in the desired position, the implant 2 is released, this is done by pressing the trigger 12. When releasing the implant 2, it elastically returns to its horseshoe shape and, consequently, modifies the shape of the patient's ear

One of the problems with this type of gun is that the implants 2 are preloaded on the gun 1 and, consequently, if the predefined position does not cause the desired aesthetic improvement in the patient, a new gun 1 preloaded with a new implant 2 and improperly placed implants should be discarded, resulting in considerable waste of medical material in good condition. Even if the trigger is accidentally pressed before any surgical procedure, the gun releases the implant and it should be discarded since returning it to its initial position may be unsafe due, among others, to the presence of sharp elements. To solve this problem, the present invention discloses, with reference to Figure 2, a refill device 3 of implants 2 in the gun 1.

Figure 2 shows an implant 2 that has been previously released from the gun 1 and, consequently, has modified the elongated shape with which it was preloaded and has elastically modified its shape to a horseshoe shape. The refill device 3 comprises a channel 30 intended to receive the applicator 10 of the gun 1, fastening means 31 to the gun

1 to hold the gun, a movable body 32 that has means to deform the implant

2 and thus return it to its elongated shape and pressure means 33 so that, once the implant is lengthened, press it so that it is again attached to the gun 1.

As can be seen from Figure 2, the implant 2 when free of external forces has a horseshoe shape with a curved central area and two ends, a proximal end that the user can attach to the applicator 10 at its end outermost and a distal end that is attached to the applicator 10 by the device of the present invention.

With regard to the means of attachment 31 to the gun, an exemplary embodiment can be by means of a clamp, as shown in Figure 2, this clamp can be configured to be attached to the gun through the applicator 10 .

On the other hand, the recharging device 3 comprises a movable body 32 whose function is to perform a longitudinal displacement with respect to the channel 30 and, consequently, with respect to to the applicator 10 of the gun 1. This longitudinal displacement has the function of performing a deformation of the implant 2

The operation mode of the refill device 3 starts by the arrangement of the gun 1 in the refill device 3 which will be described with reference to figure 3. As can be seen in figure 3, the movable body comprises an element flattener 320 that is located vertically at a height higher than the canal but less than that of the implant in the horseshoe-shaped position, that is, is located at a perpendicular distance from the channel such that it can come into contact with the curved area of the implant 2, that is to say an intermediate zone between the distal and proximal ends of implant 2.

Furthermore, it is noted that the refill device 3 comprises a fixed body, that is, without relative movement with respect to the gun 1 comprising the clamping means 31 and, optionally, the pressure means 33 and a moving body 32 comprising the flattening element 320. In the embodiment of FIG. 3, the pressure means have a union with a rotational capacity to the fixed body. This rotation-capable joint can be used to have a substantially arcuate surface 331 that can be configured to exert the longitudinal displacement in the movable body 32. Once the gun 1 is fixed to the refill device 3, the flattening is carried out of the piece illustrated in Figure 4. The user, by means of longitudinal displacement means along the channel, displaces the flattening element that deforms the implant 2 as it travels over the channel. In the example shown in Figure 2 and, more specifically in Figure 3, the flattening element 320 has a substantially cylindrical shape and can be a roller.

The longitudinal movement is carried out by the action of the user who can either directly move the mobile body 32 or, as shown in Figure 4, press an element with an arcuate surface 331 that executes a longitudinal movement of the mobile body.

Once the flattening element 320 has made a path flattening substantially on the implant surface, for example, about 80% of its total length, the distal end of the implant 2 is attached to the applicator 10 which will be explained more detail in reference to figure 5.

To perform this support, it is enough to exert a pressure near the distal end of the implant 2, in particular, in the vicinity of the means for holding the implant 2 to the applicator 10. In a particular example, the means for holding the implant can be by means of the trigger 12 of the applicator 10, making a force in this direction substantially opposite to the force for the release of the implant 2 such that a clamping element associated with said trigger holds the implant 2 at its distal end.

In another exemplary embodiment, the fastening means can be for example a hole disposed in the implant 2 through which a pin arranged in the applicator passes. The recharging device has a projection 330 whose function is to press as close as possible to said hole in order to hold the implant 2 back to the applicator 10 in a flattened form.

In order to press the implant 2 by the protrusion 330 of the recharging device it is possible that the hole of the applicator 10 does not coincide perfectly with the pin of the applicator 10, therefore, the action of the user may be required by acting on the trigger 12 of the applicator 10 in order to match said elements and subsequently perform the pressure by the protrusion 330.

In addition to the features mentioned in reference to Figures 1 to 5, the recharging device 3 may have elastic means for returning the recharging device to the initial position.

Claims

one . Otoplasty implant recharge device characterized in that it comprises:

• a channel for receiving an implant placement gun with a horseshoe-shaped implant with its proximal end attached to said gun;

• means of attachment to the gun;

• a flattening element arranged on the channel; Y

• a pressure element;

wherein the flattening element is disposed between the two ends of the implant and comprises means of longitudinal displacement along the channel to deform the implant and in which the pressure element presses the distal end of the implant to the gun.

2. Device according to claim 1 characterized in that the pressure element is connected to a fixed body comprising the channel and the flattening element is connected to a mobile body.

3. Device according to claim 2, characterized in that the pressure element is connected with rotation capacity to the fixed body

Device according to claim 3, characterized in that the pressure element comprises an arcuate surface in contact with the moving surface, so that the rotation of the pressure element causes a longitudinal movement of the flattening element.

5. Device according to any of the preceding claims, characterized in that it comprises guiding means for the displacement of the flattening element.

Device according to any one of the preceding claims, characterized in that the means for holding the gun are means for holding pressure.

7. Device according to claim 6 characterized in that the means for holding the gun comprise a clamp.

Device according to any one of the preceding claims, characterized in that the flattening element is suitable for deforming metal implants.

Device according to any one of the preceding claims, characterized in that it is made of at least 85% plastic, preferably at least 95% plastic.

10. Device according to any of the preceding claims, characterized in that it comprises a maximum of 10% stainless steel, preferably a maximum of 5%.