WO2014167381A1

WO2014167381A1 - Preformed tissue expander for ear reconstruction

Info

Publication number: WO2014167381A1
Application number: PCT/IB2013/052830
Authority: WO
Inventors: Diego PENAGOS; Emiliano Torres; Manuel Torres
Original assignee: Penagos Diego; Emiliano Torres; Manuel Torres
Priority date: 2013-04-09
Filing date: 2013-04-09
Publication date: 2014-10-16

Abstract

The present invention relates to a definitive preformed expander implant for ear reconstruction, using a reconstruction method which involves expanding autologous (the patient's own) tissues, ideally performed in one surgical operation, wherein said tissue is expanded by injecting saline solution into the implant designed, which may be filled with this liquid in order to obtain the final shape of the ear structure. Thus, with the method of insertion and expansion by means of the expander of the present invention, it is possible to avoid any kind of tissue injury during the filling process, this being a common complication with other, prior art reconstruction methods. Moreover, since the materials used in the present invention are biocompatible, the possibility of rejection thereof is also very low, which is another advantage over some of the existing reconstruction methods.

Description

PREFORMED TISSULAR EXPANSOR FOR RECONSTRUCTION

HANDSET

TECHNICAL FIELD

The present invention relates to a preformed expander implant for atrial reconstruction, which corresponds to an alternative, technique or reconstruction method that involves an expansion of autologous (own) tissues that is ideally performed in a single surgical time, where said expansion is carried out through the injection of physiological solution into the designed implant, which can be filled with this liquid in order to obtain the final shape of the atrial frame. Thus, with the technique of insertion and progressive expansion by means of the preformed expander implant of the present invention it can be achieved that during the filling process there is no tissue suffering of any kind, which is a frequent complication with other reconstruction techniques existing in The state of the art. On the other hand, since the materials used in the present invention in addition to being biocompatible are of progressive filling, and therefore the possibility of complications, such as extrusion or exposure outside the skin, is very low due to progressive filling, which constitutes an advantage over the other (current) existing reconstruction techniques.

Additionally, the atrial reconstruction technique by means of the preformed expander implant of the present invention employs the use of biocompatible materials such as silicone (elastomer), widely used. for breast reconstruction, chin and hip implants, among others, where a co-injected mesh is also used to a semi-rigid platform that prevents deformation of the implant during insertion and insufflation. Thus, once the expansion is complete, the filling system is removed and the implant is placed in its final position creating the least possible impact on the patient both physically and psychologically.

BACKGROUND OF THE INVENTION

Microtia is a major malformation of the auricular pavilion that has a spectrum that ranges from a slight decrease in the size of the auricular pavilion or one of its parts to the total absence of the pavilion (anotia). This condition occurs predominantly on the right side and has a higher incidence in males, where its prevalence varies according to the regions that are evaluated from 0.5 / 1 000 to 5/10000 in different series, being higher in some groups. Ethnic, such as the Japanese population, Hispanic and Native American Indians. Thus, treatment and atrial reconstruction in patients with microtia have been, are and will be controversial topics within the branches of Plastic and Reconstructive Surgery.

At present, atrial reconstruction has multiple techniques, which range from reconstructions with costal cartilages (ribs) to prostheses with synthetic or similar materials that are supremely rigid and that lead to the problem of cause of extrusions with consequences catastrophic for the patient, where all these existing techniques require at least two surgical procedures to do the total reconstruction.

Thus, within these atrial reconstruction techniques is the one described in US 5092348 which refers to an implantable device for tissue expansion (tissue) which comprises an outer surface layer made of silicone elastomer, so less a portion of which contains a texture or open cell structure, where said textured surface decreases the posterior capsular contracture and provides a non-slip surface to hold the device in position and thus allow differential expansion, where said device can be Used for tissue expansion in any part of the body where the temporary implantation operation is desired, said device then comprises a cover or biocompatible that forms an expandable chamber and has means for injecting fluid into the chamber from a hypodermic needle. This document teaches a plurality of tissue expanders in general, which are widely used in plastic surgery and which are coincidentally also used in atrial reconstruction in which said expander is first used to stretch the skin and after a certain time, it is removed and removed. place a definitive rigid implant, with the skin already stretched, which would decrease the chances of exposure of the rigid implants. However, the device described in this document has the disadvantage that it does not have a semi-rigid system located at the back of the implant that serves as a base, such as a mesh to prevent deformation of the implant during progressive filling of the implant (process expansion), a fact that also implies that more than one procedure is required for the implant to be installed in the patient satisfactorily, a fact that is undesirable for patients, as previously mentioned.

On the other hand, JP 7194634 discloses an improved inflatable prosthesis that radially supplies a pressure along the current length of the urethra by mounting a part of an elastomeric member on a structure member and the other part on the front end of a balloon, and partially restricting the inflation of the prosthesis in the axial direction when the balloon expands, where the balloon is located around an internal housing and is connected to the housing in the front connection positions and the rear connection position, of such that the space formed between the globe and the internal housing is sealed and the air cannot escape. The balloon also has a cylindrical plug connected to the front end of the housing and which promotes the internal expansion of tissue and prevents the inflatable prosthesis once located from moving from its initial position.

Similarly, CN 101366674 discloses an atrial reconstruction apparatus and relates to a skin or tissue expander used in an ear reconstruction operation, where the apparatus of Reconstruction comprises an air bag for formation and expansion and accessories thereof as well as memory alloy plates embedded in protruding positions. Likewise, this invention combines the expander and a support together as a single element by making use of the physiological function related to the fact that the skin tissue can be expanded and molded under a certain tension and a design principle of formation of a bionic pleural cavity, in order to implant a "growing" support directly under the skin of a missing area in the ear, thereby adjusting the ability of the air bag to achieve the effect of "ears growing" and finally adjust the shape

However, the invention described in this state of the art document is based on the use of a device that is filled with air in order to make an implant of a part of the body, especially the ear, but it is important to consider the fact that The filling material of the implant device is not biocompatible but simply air, which presents the same drawback as defined above for JP 7194634. In addition, this document mentions "alloy plates", which is considered as a rigid material, a combination of materials such as gold (which is inert to the human body and does not affect it in any way), where these alloy plates seem to guide the expansion, that is, between the walls of a rigid material is guided the expansion, but still presenting stiffness in the walls, which predisposes to exposure. However, US 201 1270391 mentions an invention that is related to a more permanent inflatable tissue expander or prosthesis, suitable to be preferably implanted in a breast, wherein said tissue expander includes a perforable self-sealing anterior portion that forms a cavity that is filled, and a posterior portion that is puncture resistant. Thus, the anterior portion includes an elastomeric silicone-based material that has a mesh embedded there. The rear portion includes a first compound protector and a second compound protector, where each compound protector includes an arrangement of puncture resistant members and a flexible substrate having a first side on which the puncture resistant members are disposed on a separate form

In addition to what has been described above, it is possible to declare that the most commonly used atrial reconstruction techniques are those defined in the Brent B documents, Technical Advances in Ear Reconstruction with Autogenous Rib Cartilage Grafts: Personal Experience with 1200 Cases (Technical Advances In Ear Reconstruction With Autogenous Rib Cartilage Grafts: Personal Experience With 1200 Cases), Plastic and Reconstructive Surgery, 104: 319-1999; and Nagata S., A New Method Of Total Reconstruction Of Microtia (A New Method Of Total Reconstruction Of The Auricle For Microtia), Plastic and Reconstructive Surgery {Plastics And Reconstructive Surgery), 92: 187 - 1993, whose authors marked a milestone with its working algorithms using costal cartilage. However, these are techniques whose learning curve is too extensive and complex, which determines a low Reproducibility in inexperienced hands, at the same time that they are therapeutic alternatives not exempt from possible serious complications and that require multiple interventions to achieve an adequate result, a fact that is unwanted for the patient and their adequate recovery.

However, a widely used alternative today is the use of porous polyethylene prostheses, whereby excellent results are obtained even by reconstruction in a surgical time, such as those described in the documents Reinisch J., Lewin S., Reconstruction of Ear Using a Porous Polyethylene Frame and Temporoparietal Fascia Flap {Ear Reconstruction Using A Porous Polyethylene Framework And Temporoparietal Fascia Flap), Facial Plastic Surgery {Facial Plastic Surgery) 2009, Volume 25, Number 3, 181-189; Driscoll D., Lee J., Combination of Scalp Tissue with Total Reconstruction of Porous Polyethylene Ear in Burned Patients {Combinig Scalp Tissue Expansion With Porous Polyethylene Total Ear Reconstruction In Burned Patients), Annals of Plastic Surgery {Annals Oí Plastic Surgery ), February 2010, Volume 64, Number 2, 183-186; Romo T., Aesthetic Microtia Reconstruction With Medpor, Aesthetic Microtia Reconstruction With Medpor, 2008, Volume 24, Number 1, 120-128; and Iwanyk P. et al., Innovation in the Reconstruction of the Dysgenic Auricular Pavilion with Expanded and Implant Tissue, Ibero-Latin American Plastic Surgery, Volume 33, Number 2, April - May - June 2007, 123 - 128, where the most frequent complications that occur with these techniques are the exposure of the frame as well as its fracture, which It determines the withdrawal of the same after a period of use by the patient, a fact that requires an additional surgical procedure that is uncomfortable and very expensive for the patient and requires recovery.

In accordance with the above, it can be clearly seen that there is currently no atrial reconstruction technique that is reproducible in the hands of surgeons with little experience in the field. Likewise, it is unknown a technique that solves the problem of an appropriate atrial frame and a correct soft tissue pocket in the same operative act, thus avoiding carrying out a plurality of surgical procedures that are uncomfortable and costly for patients. . Therefore, there is a need to design and implement a device to carry out an ear implant technique that allows a single simple, low-cost surgical procedure to be performed and does not require a very complicated line of learning, while It gives the patient the appropriate shape to the ear, and that can solve both the problem of the atrial frame and the pocket jointly.

BRIEF DESCRIPTION OF THE FIGURES

Figure 1 corresponds to a flat front view of the tissue expander of the present invention.

Figure 2 corresponds to a perspective view of the exploded view of the expander of Figure 1. Figure 3 corresponds to a flat side view of the tissue expander of Figure 1.

Figure 4 corresponds to a perspective view of the expander of Figure 1 showing the stages of filling thereof and its evolution in a certain period of time after implantation in the patient.

Figure 5 corresponds to a flat top view of the tissue expander of Figure 1 simulating its location next to the skull.

DETAILED DESCRIPTION OF THE INVENTION

The present invention corresponds to a preformed expander implant (1) corresponding to a prosthesis consisting of an expanded implant that allows the prosthesis to gradually vary until the final dimensions are achieved, and thus reducing the risk of skin exposure. (extrusion of implanted material).

The preformed expander implant (1) comprises the following components or parts:

• An expanded zone (2) that corresponds to the upper part of the expander (1) and is the one that is filled inside with the fluid that allows the final implant to be shaped; • A base (3) that corresponds to a mesh and is located at the bottom of the expander (1);

• A semi-rigid platform (4) located between the expandable area (2) and the base (3) that allows the expander (1) to have a less flexible structure and can adapt to the natural shape of the patient's skull without deforming the implant;

• Some holes (5) that correspond to holes that cross the entire expander (1), thus giving a more natural shape to the implant, which represent the negative anatomical accidents of the ear, that is, those that are sunk in any ear normal; Y

• A hose (6) located on the side of the expander (1) and allowing fluid to enter the expandable area (2), in addition to a valve that prevents the leakage of the filler material, and through which it inject it.

Thus, the preformed expander implant (1) is manufactured from an elastomeric material, preferably silicone, and is reinforced at its base (3) and perimeter by a co-injected mesh that next to the semi-rigid platform (4), It provides the necessary structure to prevent implant contraction due, in many cases, to the force of skin contraction.

Likewise, the hose (6) is also made of the elastomeric material as well as the rest of the preformed expander implant (1) and allows the fluid to enter the expandable area (2), through a valve (61), where these two elements are connected by means of a connector (62) that is located in the part internal side of the implant (1), that is, the one that is close to the patient's skull when the implant is placed, where the hose inlet coincides with an anatomical accident called "tragus" that every normal ear has in mind, and allows the hose (6) can be removed once the expander (1) is located in its final position in the patient's ear, placing a plug (not shown) inside said hose (6), sectioning and removing what is left over from the hose (6). In addition, the valve (61) has a variable measurement in centimeters and is placed below the skin at a desired and planned distance based on each patient.

In one embodiment of the invention, the valve (61) is included directly in the expander implant (1), that is, the hose (6) has a minimum length or is absent, so that the process of progressive filling of the Implant (1) is done directly on the side of it and not remotely by means of the hose (6), where in this mode the valve (61) is punctured percutaneously.

Additionally, the preformed expander implant (1) comprises a flap (7) located in the anterior part of the patient's ear, where said flap (7) is folded so that the expander (1) can be joined with the patient's skull (9) . This (7) flap is present to fix the ear to the skull (9), where it is located in the anterior part of the implant (1) so that when the ear is lifted from the skull (9), the implant (1) is not move from its place, where a groove (8) that corresponds to the back is formed, that is, what is behind the ear. The expansion of the implant (1) is in the range of approximately 6 to 8 times its height, preferably 7.66 times its height, starting from a thickness of approximately 1.5 mm to reach the final approximately 1 1 mm, which corresponds to the approximate natural thickness of an ear, with a total filling capacity of approximately 6 ml.

Finally, the fluid that is entered through the valve (61) of the hose (6) and that allows the filling of the expandable area (2) corresponds to a physiological solution, which has the characteristics of being a hypotonic and sterile solution that It will remain perennial inside the implant.

The tissue expander (1) of the present invention was designed and manufactured based on 14 variables of anatomical parameters in human otograms, as shown in Table 1, where said variables allow the implant to be as close to a human ear as possible. standard or average and thus allow the patient to have a life as normal as possible.

Table 1 . Study variables in otograms.

HELIX WIDTH

ROOT WIDTH OF ANTIHELIX

NAVICULAR FOSS WIDTH

NAVICULAR FOSA HEIGHT

CONCHA WIDTH

CONCHA HEIGHT

CHANNEL CHANNEL WIDTH ABOVE THE BISECTRIZ

CONCHA CIMBA LENGTH

CONCHA CIMBA WIDTH

Claims

one . A preformed expander implant (1) corresponding to a prosthesis consisting of an expanded implant that allows the prosthesis to gradually vary until the final dimensions are achieved, characterized in that it comprises:

• an expanded zone (2) that corresponds to the preformed upper part of the implant (1) and is the one that is filled inside with the fluid that allows the final implant to be shaped;

• a bone (3) located at the bottom of the implant (1);

• a semi-rigid platform (4) used between the expansion zone (2) and the bone (3) that allows the expander (1) to have a less flexile structure and allow the back of the ear (towards the skull) to be smoother posiole, thus avoiding the "balloon" effect and allow the reconstructed ear not to deform easily;

• holes (5) corresponding to holes that pass through the entire expander (1), thus giving a shape similar to a human ear; Y

• a hose (6) uóicada in the lateral part of the expander (1) and that allows the entrance of the fluid to the zone expanded (2).

2. The preformed expander implant (1) according to claim 1, characterized in that the bone mesh (3) is a co-injected mesh that reinforces both the bone (3) and the perimeter.

3. The preformed expander implant (1) according to claim 1, characterized in that the hose (6) comprises a valve (61) through which the fluid is introduced into the expansion zone (2) and a connector (62) which is uóica in the internal lateral part of the expander (1) and makes the direct connection between the hose (6) and the zone expanded (2).

4. The preformed expander implant (1) according to claim 1, characterized in that it further comprises a flap (7) located on the anterior part of the patient's ear, wherein said flap (7) folds in order to join the expander ( 1) with the skull (9) of the patient.

5. The preformed expander implant (1) according to claim 4, characterized in that the flap (7) also comprises co-injected mesh.

6. The preformed expander implant (1) according to claim 1, characterized in that the expansion of the implant is in the range of about 6 to about 8 times its height, preferably 7.66 times its height, where the final expander counts with a thickness of 1.5 mm to 1 1 mm.

7. The preformed expander implant (1) according to any of the preceding claims, characterized in that the fluid that is entered through the hose (6) corresponds to a physiological solution, which has the characteristics to be a hypotonic and sterile solution that will remain perennial inside the implant The preformed expander implant (1) according to the preceding claims, characterized in that the implant (1) and the hose (6) are manufactured from an elastomeric material.

The preformed expander implant (1) according to claim 8, characterized in that the elastomeric material is silicone.