WO2014167381A1 - Expanseur tissulaire préformé pour la reconstruction auriculaire - Google Patents

Expanseur tissulaire préformé pour la reconstruction auriculaire Download PDF

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Publication number
WO2014167381A1
WO2014167381A1 PCT/IB2013/052830 IB2013052830W WO2014167381A1 WO 2014167381 A1 WO2014167381 A1 WO 2014167381A1 IB 2013052830 W IB2013052830 W IB 2013052830W WO 2014167381 A1 WO2014167381 A1 WO 2014167381A1
Authority
WO
WIPO (PCT)
Prior art keywords
implant
expander
preformed
ear
reconstruction
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/IB2013/052830
Other languages
English (en)
Spanish (es)
Inventor
Diego PENAGOS
Emiliano Torres
Manuel Torres
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
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
Application filed by Individual filed Critical Individual
Priority to PCT/IB2013/052830 priority Critical patent/WO2014167381A1/fr
Publication of WO2014167381A1 publication Critical patent/WO2014167381A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/02—Devices for expanding tissue, e.g. skin tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F11/00—Methods or devices for treatment of the ears or hearing sense; Non-electric hearing aids; Methods or devices for enabling ear patients to achieve auditory perception through physiological senses other than hearing sense; Protective devices for the ears, carried on the body or in the hand
    • A61F11/20—Ear surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/18—Internal ear or nose parts, e.g. ear-drums
    • A61F2002/183—Ear parts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001—Designing or manufacturing processes
    • A61F2240/002—Designing or making customized prostheses
    • A61F2240/004—Using a positive or negative model, e.g. moulds

Definitions

  • 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.
  • a preformed expander implant for atrial reconstruction 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.
  • 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.
  • 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.
  • 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.
  • ribs costal cartilages
  • US 5092348 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Dermatology (AREA)
  • Vascular Medicine (AREA)
  • Acoustics & Sound (AREA)
  • Otolaryngology (AREA)
  • Biophysics (AREA)
  • Physics & Mathematics (AREA)
  • Psychology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Pathology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Prostheses (AREA)

Abstract

La présente invention concerne une prothèse d'expansion tissulaire préformée et définitive pour la reconstruction auriculaire, laquelle correspond à une technique de reconstruction qui implique une expansion des tissus autologues (propres) qui s'effectue idéalement en un seule intervention chirurgicale, au cours de laquelle l'expansion s'effectue par injection d'une solution physiologique dans la prothèse façonnée, laquelle peut être remplie de ce liquide pour pouvoir obtenir la forme finale de la structure auriculaire. Ainsi, avec la technique d'insertion et d'expansion au moyen de l'expanseur de la présente invention, il est possible que le processus de remplissage soit indolore, ce qui est une complication fréquente avec d'autres techniques de reconstruction existantes de l'état de la technique. D'autre part, étant donné que les matériaux utilisés dans la présente invention sont biocompatibles, la possibilité de rejet de ceux-ci est également très faible ce qui constitue un avantage supplémentaire par rapport aux techniques de reconstruction existantes.
PCT/IB2013/052830 2013-04-09 2013-04-09 Expanseur tissulaire préformé pour la reconstruction auriculaire Ceased WO2014167381A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/IB2013/052830 WO2014167381A1 (fr) 2013-04-09 2013-04-09 Expanseur tissulaire préformé pour la reconstruction auriculaire

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IB2013/052830 WO2014167381A1 (fr) 2013-04-09 2013-04-09 Expanseur tissulaire préformé pour la reconstruction auriculaire

Publications (1)

Publication Number Publication Date
WO2014167381A1 true WO2014167381A1 (fr) 2014-10-16

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PCT/IB2013/052830 Ceased WO2014167381A1 (fr) 2013-04-09 2013-04-09 Expanseur tissulaire préformé pour la reconstruction auriculaire

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2023000160A (ja) * 2021-06-17 2023-01-04 学校法人近畿大学 人工耳介および人工軟骨組織の骨格構造およびそれを用いた人工耳介
US12016752B2 (en) 2018-11-12 2024-06-25 EarGear, LLC Corrective apparatus for deformed external ear

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0324234A1 (fr) * 1987-12-17 1989-07-19 Dow Corning Wright Corporation Dilatateur de tissu et procédé de fabrication et d'utilisation
US5092348A (en) * 1989-01-17 1992-03-03 Mcghan Medical Corporation Textured tissue expander
WO2009014908A1 (fr) * 2007-07-23 2009-01-29 Henry Stephenson Byrd Correction d'oreilles malformées
CN101366674A (zh) * 2007-08-15 2009-02-18 石锦 耳廓再造器
WO2010093371A1 (fr) * 2009-02-10 2010-08-19 Henry Stephenson Byrd Dispositif de moulage d'oreille pour correction d'oreilles malformées

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0324234A1 (fr) * 1987-12-17 1989-07-19 Dow Corning Wright Corporation Dilatateur de tissu et procédé de fabrication et d'utilisation
US5092348A (en) * 1989-01-17 1992-03-03 Mcghan Medical Corporation Textured tissue expander
WO2009014908A1 (fr) * 2007-07-23 2009-01-29 Henry Stephenson Byrd Correction d'oreilles malformées
CN101366674A (zh) * 2007-08-15 2009-02-18 石锦 耳廓再造器
WO2010093371A1 (fr) * 2009-02-10 2010-08-19 Henry Stephenson Byrd Dispositif de moulage d'oreille pour correction d'oreilles malformées

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12016752B2 (en) 2018-11-12 2024-06-25 EarGear, LLC Corrective apparatus for deformed external ear
JP2023000160A (ja) * 2021-06-17 2023-01-04 学校法人近畿大学 人工耳介および人工軟骨組織の骨格構造およびそれを用いた人工耳介
EP4356936A4 (fr) * 2021-06-17 2025-06-25 Kinki University Structure squelettique pour pavillon artificiel et tissu cartilagineux artificiel, et pavillon artificiel l'utilisant
JP7774794B2 (ja) 2021-06-17 2025-11-25 学校法人近畿大学 人工耳介および人工軟骨組織の骨格構造

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