WO2023038513A1 - Instruments for minimally invasive insertion of implants that are fillable in situ - Google Patents

Instruments for minimally invasive insertion of implants that are fillable in situ Download PDF

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Publication number
WO2023038513A1
WO2023038513A1 PCT/MX2022/050076 MX2022050076W WO2023038513A1 WO 2023038513 A1 WO2023038513 A1 WO 2023038513A1 MX 2022050076 W MX2022050076 W MX 2022050076W WO 2023038513 A1 WO2023038513 A1 WO 2023038513A1
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Prior art keywords
implant
neck
implants
instruments
situ
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PCT/MX2022/050076
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Spanish (es)
French (fr)
Inventor
Tomás Ramón IBARRA HURTADO
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Ibarra Hurtado Tomas Ramon
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Publication of WO2023038513A1 publication Critical patent/WO2023038513A1/en

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    • 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

Definitions

  • the present invention is related to the technical field of medicine and more specifically to implants, since it provides instruments for placing implants that can be filled in situ in a minimally invasive manner.
  • plastic, aesthetic, reconstructive or reconstructive surgery is defined as the surgical specialty in charge of restoring the anatomical or functional integrity of the human body, altered by physical, congenital or acquired defects.
  • Aesthetics we will specify the term "Aesthetics” and not the other designations, because we would exceed the objective of this communication. Aesthetics comes from the Greek “aisthetikos”: that which is endowed with sensation and is perceived by the senses. According to the definition, it concerns beauty.
  • Plastic surgery today encompasses cases of burns, reconstructions, correction of malformations, etc. It is a unique specialty in the sense that its field of action is not limited, but rather encompasses different minor specialties.
  • Silicone for medical use has a series of characteristics such as its biocompatibility (it does not cause undesirable effects in the patient or recipient of the implant), its biodurability (it does not deteriorate over time), the fact that it is a hydrophobic material ( water repellent ) , has great chemical and thermal stability and low surface tension . From then on, silicone implants with high molecular weight molecules began to be used, which became very popular in the 1970s because they had a low rupture rate (a frequent problem in the first implants), although they were susceptible. to suffer other complications such as capsular contractures or movement of the implants.
  • buttock implants are similar to the natural buttocks achieving very good results; its volume can vary between 200, 300 and 350 cc, with a unique and specific design for the gluteal region with an anatomical oval shape.
  • implants are considered a second option to increase the volume of this area, due to the high percentage of complications reported for gluteal augmentation with implants between 30-50% vs 10-15 % for fat grafting, however, in thin patients who do not have enough fat, implants will continue to be the first choice.
  • Gluteal implants are also used in situations of: ptosis (dropping of the buttocks), loss of muscle or asymmetry.
  • the device described in the application US2009254179 has the ability to be inserted in a minimal way invasive and to detect and communicate the appearance of loss of integrity in the casing of practically any implant.
  • the device has a rupture sensor placed on the casing, which helps detect the status of the implant and if there is a leak, as well as any change in the physicochemical properties of the implant.
  • a seal is placed over the rupture sensor to protect it.
  • Implantable cardioverter - defibrillators Monitoring for leakage or leakage in implants (such as breast implants , pacemakers , implantable cardioverter - defibrillators , other unreliable devices and other related devices ) .
  • the device for minimally invasive implantation described in the application US2009254179 (Al), is made up of a casing; and a support material disposed within the housing, the support material being adapted to be compressed for implantation and subsequently expanded; where said support material comprises a hydrogel or hydrophilic material, which must be dehydrated before implantation.
  • the hydrogel dehydrated or hydrophilic material is hyperosmotic such that it expands after implantation due to ingress of water through the shell from surrounding tissue.
  • the shell described in application US2009254179 (Al) is configured to be a breast implant, pectoral implant, calf implant, biceps implant, buttock implant, penile implant, gastric implant, or peritoneal implant. ; and, said cover has a plurality of silicon supports forming a grid.
  • US2008058926 (Al) describes an unreliable implant having a self-sealing valve that is detachably coupled to the distal end of one of the tubes such that a portion of the distal end of the tube extends through the self-sealing valve. self sealing . It is mentioned that the second tube is threaded into the interior of the balloon in position of the valve to secure the distal end of the second tube that extends through the valve.
  • a breast prosthesis which consists of an outer casing of a biologically proven inert material that encloses the fluid and/or gas compartments to form a prosthesis of varied characteristics.
  • the prosthesis contains at least one microcompartment in a hierarchical layered array, each of which contains a filler consisting of liquid, air, gas, gel, or a combination thereof. The amount of filler injected into each microcompartment varies according to the size and shape that the recipient individual seeks to achieve.
  • micro compartments facilitates the ability to customize the prosthesis (ie, if a smaller prosthesis is warranted, a clinician can remove the filler from the prosthesis with a medical instrument, or even remove the micros). compartments to change the specific gravity of the prosthesis). Modifying the number of microcompartments and the amount of filler in them helps the individual recipient to achieve an implant customized for their specific needs.
  • the injected filler may further comprise a fluorescent agent that serves as a visual aid to medical professionals when examining the implant in the dark under blue light (eg, ultraviolet light).
  • a fluorescent agent serves as a visual aid to medical professionals when examining the implant in the dark under blue light (eg, ultraviolet light).
  • the fluorescent agent creates an incentive in the person who you receive for regular follow-up with your doctor for checkups because the examining doctor will be able to tell if the implant has dislodged from the implant site or if leaks are present when viewed under blue light.
  • the fluorescent agent in the filler makes it easy for a medical professional to examine the entire denture structure with minimal invasiveness.
  • a prosthesis useful for implanting in soft tissue comprising: an outer layer; at least one micro compartment encapsulated by the outer casing; a flexible fill tube; and an injectable port ; wherein the outer shell of the prosthesis further comprises a polymer with ductile and memory-like structural characteristics; wherein the micro compartments of the prosthesis are removable and further comprised of a polymer with memory-like and ductile structural characteristics, wherein the micro compartments are arranged in a hierarchical layering scheme as a means of reducing gravity specific total of the prosthesis; wherein the flexible filler tube functions as a means to traverse the denture fillers into the micro compartments; and wherein the injectable port functions as a means to modify the volume of the microcompartments.
  • the prosthesis further comprises at least one flexible implant tube and an injectable port in which at least one removable microcompartment extends outwardly therefrom.
  • the prosthesis also has a means to open and close the injection port of the implant tube; as well as a polymer plug formulated to seal the flexible implant tube.
  • the described prosthesis has the advantages that the bag body can be implanted in the buttock between the two buttocks after being rolled into a cylindrical body and then filled with filling materials, whereby the dimension of the notch is small and the pain of the patients is small ; allowing patients to recover soon after operations.
  • the guide tube can also be found from the notch at any time as needed after operations, the buttock height can be increased or decreased by injecting or removing the filler materials, or the prosthesis can be completely removed from the notch original and cleanly when not needed .
  • the previously described documents do not describe that they are made up of instruments with the necessary characteristics first to introduce a trocar with an anatomical or round dissector balloon to separate the muscles in a minimally invasive way and create a space between the gluteal muscles without need to cut them, second that allows immediately after the placement with the help of the trocar with round or anatomical bi-profile or double-profile implants configured to be filled in situ to the desired size.
  • Another difference between the instruments for placing implants that can be filled in situ in a minimally invasive manner that is the subject of the present invention and the documents described, is that none of them describes a guide and a trocar that, with the complement of their characteristics, prevent air leakage when it is applied. inject an expander that will generate the space between the muscles, as well as the material with which the implant will be filled.
  • the object of the present invention to provide an instrument for placing implants that can be filled in situ in a minimally invasive manner, made up of a trocar, a round and anatomical bi-profile pneumatic dissector balloon that allows a space to be made in the first step. between the muscles without the need to incise them, allowing immediately after in the second step to place the configured implants to be filled in situ to the desired size.
  • Another object of the present invention is to provide an instrument for placing implants that can be filled in situ in a minimally invasive manner that has an implant that is round and anatomical bi-profile configured to be filled in situ to the desired size, to subsequently allow the length of the neck to be adjusted. of said implant is imbricated on its own axis towards the interior of the implant, to later introduce the cap and avoid any type of leakage.
  • Another object of the present invention is a set of instruments for placing implants that can be filled in situ in a minimally invasive manner, which allows the placement of said implant to be through small incisions of 1. 5cm, respecting the gluteus muscle, which will not need to be incised but only separated, with the main advantages of reducing complications, pain, rapid recovery, rapid return to work and physical activity, among others, and for the above a better cosmetic result due to the double profile that offers a greater projection of the gluteal area in both the round and anatomical implants.
  • Figure 1 shows a perspective view of the instrument trocar for placing implants that can be filled in situ in a minimally invasive manner.
  • Figure 2 shows a top perspective view of the tube and the guide that make up the trocar of the instruments for placing implants that can be filled in situ in a minimally invasive manner.
  • Figure 3 shows a bottom perspective view of the tube and the guide that make up the trocar of the instruments for placing implants that can be filled in situ in a minimally invasive manner.
  • Figure 4 shows a perspective view of the guide and valve of the instruments for placing implants that can be filled in situ in a minimally invasive manner.
  • Figure 5 shows a perspective view of the instrument guide valve for placing implants that can be filled in situ in a minimally invasive manner.
  • Figure 6 shows a detailed view of the instrument guide valve for minimally filling implants in situ. invasive, where the membrane and protuberances can be seen.
  • Figure 7 shows a front view of the implant of the instruments for placing implants that can be filled in situ in a minimally invasive manner.
  • Figure 8 shows a perspective view of the implant and cap of the instrumentation for placing implants that can be filled in situ in a minimally invasive manner.
  • Figure 9 shows a perspective view of the transparency of the implant and cap of the instrument to place implants that can be filled in situ in a minimally invasive manner, where the neck of the implant is imbricated.
  • Figure 10 shows a perspective view of the transparency of the implant and cap of the instrument to place filled implants in situ in a minimally invasive manner, where the neck of the implant is imbricated, where the assembly between the diaphragms and valves can be seen.
  • Figure 11 shows a detailed view of the assembly of the plug diaphragms with the implant neck valves of the instrumentation to place implants that can be filled in situ in a minimally invasive manner.
  • Figure 12 shows a front view of the implant of the instruments for placing implants that can be filled in situ in a minimally invasive manner, with the plug in place.
  • Figure 13 shows a front view of the implant placed over the trocar of the instrumentation to place implants that can be filled in situ in a minimally invasive manner.
  • Figure 14 shows a front view of the transparency of the dissector balloon placed over the trocar of the instruments to place implants that can be filled in situ in a minimally invasive manner.
  • Figure 15 shows a detailed view of the transparency of the dissector balloon placed over the trocar of the instruments to place implants that can be filled in situ in a minimally invasive manner.
  • Figure 16 shows a front view of the transparency of the dissector balloon placed over the trocar of the instruments to place implants that can be filled in situ in a minimally invasive manner, where the dissector balloon can be seen, without air.
  • Figure 17 shows a front view of the transparency of the dissector balloon placed over the trocar of the instruments to place implants that can be filled in situ in a minimally invasive manner, where the injection of air into the dissector balloon can be seen.
  • Figure 18 shows a diagram of the generation of space in the gluteal muscle by means of the dissector balloon of the instrumentation to place implants that can be filled in situ in a minimally invasive manner.
  • Figure 19 shows a diagram of the placement and filling with silicone of the implant in the space generated in the gluteus muscle by means of the dissector balloon of the instruments for placing implants that can be filled in situ in a minimally invasive manner.
  • Figure 20 shows a diagram of the preferred position of the surgical incisions when placing implants with the instrumentation to place minimally invasive in situ fillable implants.
  • the instruments for placing implants that can be filled in situ in a minimally invasive manner are made up of at least one trocar (A) that is made up of a graduated tube (1) configured to house a guide (2) that is longer than said tube and is preferably metallic.
  • the graduated tube (1) is preferably made of a transparent material and a removable check valve (3) is placed at its upper end, which is a hollow cylinder with a larger diameter than the tube (1) and with blunt edges;
  • the upper end of said valve (3) is covered with a membrane (4), which is preferably made of silicone.
  • each section generated in the membrane (4) has at least one protrusions (6) which allow the membrane (4) to give body to maintain its shape and give it hermetic sealing to prevent the leakage of any fluid, the Which can be liquid or gas.
  • the guide (2) is inserted into the tube (1) at its upper end, passing through the incision (5) in the shape of a cross in the membrane (4).
  • the guide (2) is a preferably metallic tube that has a connector (7) at its upper end and a point at its lower end, which is preferably rounded with blunt edges and has a hole (8) that allows the passage of a fluent.
  • the connector (7) is a threaded Luer-lock hermetic fit, configured to connect a cannula, syringe, extension or three-way valve.
  • the guide (2) has multiple perforations (9) in the body near the lower end, which facilitates the injection of a fluid.
  • At least one slot is placed on the circumference of the body of the guide (2), on which a safety ring (10) is placed that allows a hermetic seal with the internal wall of the tube (1), avoiding, together with the membrane (4), the leakage of any fluid.
  • a dissector balloon (B), which is preferably made of silicone, has a bi-profile body (11) which can be anatomical or round. Said body is attached to a neck (12) which is at least half the length of the balloon. body (11), in such a way that the mouth of the neck (not illustrated) allows the introduction of the trocar (A), so that the hole (not illustrated) of the tip of the lower end of the guide (2) as well as, at least , a perforation (9) is inside the body (11), allowing a fluid to be introduced, which in the case of the dissector balloon (B) is air.
  • the dissector balloon (B) can be secured by means of a clamping mechanism (not illustrated) to ensure its position at the time of delivery. insert it between the muscle tissue, which is the place where the space will be made to place the implant, after making a small surgical incision of at least one centimeter, long enough to introduce the trocar (A) with the balloon dissector (B) in the muscle where the implant is placed, to later introduce air into the dissector balloon (B) through the guide (2) allowing a space to be made in the muscle where the implant will be placed without the need to incise, This is done quickly and easily with minimal invasion, adequate, sufficient dissection, respecting the anatomical planes with the advantage of reducing the complications that normally accompany this cosmetic procedure when using other instruments.
  • Another important advantage is that the injection of air into the dissector balloon (B) gives the opportunity to choose the appropriate shape and volume for each patient at the time of the intervention.
  • An implant (C) that is preferably made of silicone, has a bi-profile body (13) which can be anatomical or round, said body is attached to a neck (14) which has a length of at least half the body. (13), in such a way that the mouth of the neck (not illustrated) allows the introduction of the trocar (A), and its position is ensured by means of the clamping mechanism (not illustrated);
  • the hole (8) at the tip of the lower end of the guide (2) as well as at least one perforation (9) are inside the body (13), allowing a fluid to be introduced, which in the case of the implant (C ) is medical grade silicone or another biocompatible material that is easier to inject, such as hyaluronic acid for example.
  • the implant (C) is positioned in the space generated by the dissector balloon (B), in such a way that the muscle where the implant is placed is respected, which does not need to be incised but just as just separate it, with the main advantages of pain reduction, quick recovery, quick reintegration into their work and physical activity, among others, and therefore a better cosmetic result due to the double profile that offers a greater projection of the area where the implant is placed (C) either in its round shape to augment only the buttocks, or in the anatomical one. to increase gluteus and hip.
  • the silicone injection will be decided according to the volume of air that was injected into the dissector balloon (B).
  • the base of the neck (14) proximal to the body (13) of the implant (C) has at least two valves (15), allowing the neck to imbricate on its own axis towards the interior of the body (13) of the implant (C) once it is filled with silicone, which with its own internal pressure of the body (13) causes the neck to stick to the internal wall of said body, preventing leaks.
  • a silicone plug (16) whose base (17) has an anatomical shape and the stem (18) has at least two diaphragms (19) that match the number of valves (15), in such a way that they fit together by inserting the plug (16) in the mouth of the neck (14) once it is imbricated, generating a hermetic seal that prevents any type of leakage of the fluid that is inside the body (13) of the implant (C) .
  • a non-toxic adhesive preferably acrylic, can be used in the stopper (16) in such a way that the assembly of the diaphragms (19) with the valves (15) is mechanically stuck.
  • the fastening mechanisms can be rings, rubber bands, straps, glue and/or a combination of the above.
  • Example 1 Placement of gluteal implants by means of the instrumental for placing implants filled in situ in a minimally invasive way; in two steps.
  • a surgical incision of 1 to 1.5 centimeters is made in the upper area of each one of the buttocks, to later separate the external gluteus muscle from 0.5 to 1 centimeter and insert the trocar (A) with the dissector balloon (B) into the incision until it is under the gluteus maximus muscle; once there, air is injected through the metal guide (2) up to 700cc or more as the case may be; once the space or pocket below the gluteal muscle is made, the trocar (A) is removed with the dissector balloon (B); the latter can be removed from the trocar; and subsequently,
  • Second step place the implant (C) or another trocar (A) can be ready with the implant in position, so that the surgery can be performed as quickly as possible. possible time; the trocar (A) with the implant (C) is inserted until it is positioned over the space generated; later it is filled with medical grade silicone or other biocompatible material; by means of heat or with glue and with the help of surgical forceps, pressure is exerted on the neck (14) of the implant (C) to imbricate it inside the body (13) of the implant (C) after removing the trocar ( A), allowing the pressure generated by the silicone inside the body (13) to move the neck to the internal wall of said body (13), avoiding silicone leaks when the trocar (A) is removed; Subsequently, the plug (16) is placed on the mouth of the neck (14); pressure is exerted on the plug (16) to make the diaphragms (19) of its stem (18) assemble with the valves (15) of the neck (14) of the implant (C), which generates a hermetic seal and

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

The present invention relates to instruments for the minimally invasive insertion of implants that are fillable in situ, consisting of a trocar and a round, anatomical bi-profiled pneumatic dissector balloon that creates a space between the muscles without need to incise them, enabling the subsequent insertion of an implant configured to be filled in situ to the desired size. Said implant is bi-profiled, round and anatomical, configured to be filled in situ to the desired size in order to subsequently enable the imbrication of the length of the neck of said implant on its own axis towards the interior of the implant, thereby forming a plug to prevent any leakage. The instruments for the minimally invasive insertion of implants that are fillable in situ enable the implant to be inserted through small, 1.5 cm incisions, respecting the gluteal muscle, which does not need to be incised but only separated, with the main advantages of reducing complications, pain, fast recovery, rapid return to work and physical activity, inter alia, thereby providing a better cosmetic result due to the double profile, which offers a greater projection of the gluteal area in both round and anatomical implants.

Description

INSTRUMENTAL PARA COLOCAR IMPLANTES RELLENARLES IN SITU DE MANERA MÍNIMAMENTE INVASIVA INSTRUMENTS FOR PLACING IMPLANTS AND FILLING THEM IN SITU IN A MINIMALLY INVASIVE WAY
CAMPO TÉCNICO DE LA INVENCIÓN TECHNICAL FIELD OF THE INVENTION
La presente invención se relaciona con el campo técnico de la medicina y más especí ficamente con los implantes , ya que aporta un instrumental para colocar implantes rellenadles in situ de manera mínimamente invasiva . The present invention is related to the technical field of medicine and more specifically to implants, since it provides instruments for placing implants that can be filled in situ in a minimally invasive manner.
ANTECEDENTES DE LA INVENCIÓN BACKGROUND OF THE INVENTION
Norma Acerbi Cremades ( 2009 ) sostiene que : Norma Acerbi Cremades (2009) argues that:
En términos generales , se define a la cirugía plástica, estética, reparadora o reconstructiva, como la especialidad quirúrgica encargada de restablecer la integridad anatómica o funcional del cuerpo humano , alterado por defectos físicos , congénitos o adquiridos . In general terms, plastic, aesthetic, reconstructive or reconstructive surgery is defined as the surgical specialty in charge of restoring the anatomical or functional integrity of the human body, altered by physical, congenital or acquired defects.
Precisaremos el término "Estética" y no las otras designaciones , porque excederíamos el obj etivo de esta comunicación . Estética, proviene del griego "aisthetikos" : aquello que está dotado de sensación y es percibido por los sentidos . De acuerdo con la definición, concierne a la belleza . We will specify the term "Aesthetics" and not the other designations, because we would exceed the objective of this communication. Aesthetics comes from the Greek "aisthetikos": that which is endowed with sensation and is perceived by the senses. According to the definition, it concerns beauty.
La cirugía plástica alcanza un desarrollo notable durante la segunda mitad del siglo XX gracias a las nuevas técnicas , procedimientos y materiales utili zados . Los nuevos avances han conseguido que la intervención y el postoperatorio resulten cómodos y prácticamente indoloros para los pacientes . En el Siglo XXI, la especialidad quirúrgica ha tomado un verdadero auge. Se han alejado todos los prejuicios pasados y si antes los pacientes que hablan recibido sus beneficios se callaban o lo ocultaban, en la actualidad, pregonan, vanaglorian y enfatizan los logros alcanzados. Plastic surgery reached a remarkable development during the second half of the 20th century thanks to the new techniques, procedures and materials used. New advances have made the intervention and the postoperative period comfortable and practically painless for patients. In the 21st century, the surgical specialty has taken a real boom. All past prejudices have been removed and if before the patients who had received their benefits were silent or hid it, today they proclaim, boast and emphasize the achievements achieved.
Ya no es una cirugía para las elites, ni tampoco solo para mujeres. Por el contrario, se practica en los hospitales públicos; es para ambos sexos; sin limite de edad y variados recursos económicos. It is no longer a surgery for the elites, nor is it just for women. On the contrary, it is practiced in public hospitals; it is for both sexes; No age limit and varied economic resources.
La cirugía plástica hoy engloba casos de quemaduras, reconstrucciones, corrección de malformaciones, etc. Se trata de una especialidad única en el sentido de que su campo de actuación no está limitado, sino que abarca diferentes especialidades menores. Plastic surgery today encompasses cases of burns, reconstructions, correction of malformations, etc. It is a unique specialty in the sense that its field of action is not limited, but rather encompasses different minor specialties.
A finales del siglo XIX, concretamente en 1895, podemos encontrar la primera intervención de aumento de pecho documentada, realizada por Czerny, un cirujano de la República Checa, a partir de un lipoma o tumor benigno de la espalda de la paciente. At the end of the 19th century, specifically in 1895, we can find the first documented breast augmentation intervention, performed by Czerny, a surgeon from the Czech Republic, from a lipoma or benign tumor on the patient's back.
Desde entonces se han utilizado distintas técnicas y materiales para realizar los aumentos y reconstrucciones de pecho: se han estudiado distintos materiales, se ha invertido en investigación y desarrollo para llegar hasta donde estamos hoy. Since then, different techniques and materials have been used to perform breast augmentations and reconstructions: different materials have been studied, research and development have been invested to get to where we are today.
Como hemos apuntado, los primeros implantes mamarios podemos encontrarlos documentados a finales del siglo XIX. En torno a esos años se comenzaron a probar distintos materiales para la fabricación de los implantes, no todos con el mismo éxito: mientras que el injerto de grasa de Czerny fue todo un acierto , las inyecciones de parafina Robert Gersuny en 1899 supusieron un sinfín de complicaciones en las pacientes , obligándole a abandonar este método . As we have pointed out, the first breast implants can be found documented at the end of the 19th century. Around those years, different materials for the manufacture of implants began to be tested, not all with the same success: while the fat graft of Czerny was a complete success, Robert Gersuny's paraffin injections in 1899 caused endless complications in the patients, forcing him to abandon this method.
Durante la primera mitad del siglo XX se siguió experimentando con di ferentes materiales de lo más diversos : desde la citada parafina líquida y otras sustancias derivadas del petróleo hasta esponj as de polímeros de plástico , cartílago y otros materiales sintéticos . During the first half of the 20th century, experimentation continued with the most diverse materials: from the aforementioned liquid paraffin and other petroleum-derived substances to sponges made of plastic polymers, cartilage, and other synthetic materials.
Los resultados estéticos que ofrecían estos materiales no eran satis factorios y, más importante aún, las complicaciones que aparecían en las pacientes ( infecciones , contracturas , migraciones de los materiales a otros tej idos ) eran muy numerosas . The aesthetic results offered by these materials were not satisfactory and, even more important, the complications that appeared in the patients (infections, contractures, migration of the materials to other tissues) were very numerous.
No fue hasta la década de 1960 cuando comenzaron a utili zarse los implantes de silicona, parecidos a los que se usan en nuestros días . Los ciruj anos norteamericanos Croning y Gerow utili zaron unas bolsas de lámina de silicona rellenas de aceite de silicona para uso médico para reali zar sus implantes mamarios . It was not until the 1960s that silicone implants began to be used, similar to those used today. American surgeons Croning and Gerow used silicone foil bags filled with silicone oil for medical use to carry out their breast implants.
La silicona de uso médico tiene una serie de características como su biocompatibilidad (no provoca efectos indeseables en el paciente o receptor del implante ) , su biodurabilidad (no se deteriora con el paso del tiempo ) , el hecho de que es un material hidró fobo ( repelente al agua ) , tiene una gran estabilidad química y térmica y una baj a tensión superficial . A partir de entonces comenzaron a usarse implantes de silicona con moléculas de alto peso molecular, que se hicieron muy populares en la década de 1970 ya que presentaban un baj o indice de ruptura (un problema frecuente en los primeros implantes ) , aunque si eran susceptibles a sufrir otras complicaciones como contracturas capsulares o movimiento de los implantes . Silicone for medical use has a series of characteristics such as its biocompatibility (it does not cause undesirable effects in the patient or recipient of the implant), its biodurability (it does not deteriorate over time), the fact that it is a hydrophobic material ( water repellent ) , has great chemical and thermal stability and low surface tension . From then on, silicone implants with high molecular weight molecules began to be used, which became very popular in the 1970s because they had a low rupture rate (a frequent problem in the first implants), although they were susceptible. to suffer other complications such as capsular contractures or movement of the implants.
En la década de 1980 se generali zó la uti li zación de implantes reali zados con moléculas más pesadas y con un recubrimiento de poliuretano , que reduj eron notablemente el número de complicaciones sufridos por las pacientes . Dej aron de usarse por una asociación ( que luego se demostró errónea ) con la proli feración de lesiones tumorales . In the 1980s, the use of implants made with heavier molecules and with a polyurethane coating became general, which notably reduced the number of complications suffered by patients. They ceased to be used due to an association (later proven wrong) with the proliferation of tumor lesions.
Esto propició , sin embargo , que la investigación se centrara en los implantes de silicona con recubrimiento de elastómero de silicona : estos implantes reduj eron el riesgo de contractura capsular al mismo tiempo que daban un aspecto mucho más natural al pecho operado . Durante este tiempo se populari zaron también los implantes rellenos de solución salina . This led, however, to focus research on silicone elastomer-coated silicone implants: these implants reduced the risk of capsular contracture while giving the operated breast a much more natural appearance. Saline-filled implants also became popular during this time.
La historia de los implantes glúteos inicia en el año 1969 , utili zando en principio los mismos implantes de los senos para aumentar el volumen de los glúteos , por lo que la forma y los resultados no eran ni los adecuados ni satis factorios para las pacientes , ya que la forma es di ferente , las fuerzas y presiones a las que están sometidos los glúteos son muy distintas a las del pecho . The history of buttock implants began in 1969, initially using the same breast implants to increase the volume of the buttocks, so the shape and results were neither adequate nor satisfactory for the patients. Since the shape is different, the forces and pressures to which the buttocks are subjected are very different from those of the chest.
Actualmente la forma de los implantes de glúteo es similar a los glúteos naturales logrando muy buenos resultados ; su volumen puede variar entre los 200 , 300 y 350 cc, con un diseño único y especi fico para la región glútea con forma anatómica oval . Currently the shape of the buttock implants is similar to the natural buttocks achieving very good results; its volume can vary between 200, 300 and 350 cc, with a unique and specific design for the gluteal region with an anatomical oval shape.
Con la opción del procedimiento del inj erto de grasa, los implantes se consideran una segunda opción para incrementar el volumen de esta área , debido al alto porcentaj e de complicaciones , reportadas para el aumento glúteo con implantes entre 30-50% vs 10- 15% para el inj erto de grasa, sin embargo , en pacientes delgadas que no tienen la suficiente cantidad de grasa, los implantes continuarán siendo la primera opción . With the option of the fat graft procedure, implants are considered a second option to increase the volume of this area, due to the high percentage of complications reported for gluteal augmentation with implants between 30-50% vs 10-15 % for fat grafting, however, in thin patients who do not have enough fat, implants will continue to be the first choice.
También se utili zan los implantes glúteos en situaciones de : ptosis ( calda de los glúteos ) , pérdida del músculo o asimetría . Gluteal implants are also used in situations of: ptosis (dropping of the buttocks), loss of muscle or asymmetry.
Con el paso del tiempo se han desarrollado diversas técnicas , asi como diversos instrumentales e implantes utili zados en las cirugías estéticas motivo por el cual se reali zó una búsqueda del estado de la técnica sobre instrumental para colocar implantes rellenables , donde se encontró la solicitud de patente de Estados Unidos número US2009254179 (Al ) , publicada el 08 de octubre de 2009 con el titulo "MÉTODO Y APARATO PARA IMPLANTES MÍNIMAMENTE INVAS IVOS" , dicha solicitud se refiere a un di spositivo y un método capaces de proporcionar una inserción mínimamente invasiva de implantes mamarios rellenables con solución salina, acuosos u otros fluidos mientras se previene la deflación y/o migración, asi como el monitoreo de fugas o fugas en implantes ( tales como implantes mamarios ) , marcapasos , des f ibriladores automáticos implantables , otros dispositivos infiables y otros dispositivos relacionados ) . El dispositivo descrito en la solicitud US2009254179 (Al ) tiene la capacidad de insertarse de forma mínimamente invasiva y de detectar y comunicar la aparición de pérdida de integridad en la carcasa de prácticamente cualquier implante . El dispositivo cuenta con un sensor de rotura colocado sobre la carcasa, el cual ayuda detecta el estado del implante y si existe una fuga, asi como cualquier cambio en las propiedades fisicoquímicas del implante . Sobre el sensor de rotura se coloca un sello para protegerlo . With the passage of time, various techniques have been developed, as well as various instruments and implants used in aesthetic surgeries, which is why a search was made for the state of the art on instruments to place fillable implants, where the request for United States patent number US2009254179 (Al), published on October 8, 2009 with the title "METHOD AND APPARATUS FOR MINIMALLY INVASIVE IMPLANTS", said application refers to a device and a method capable of providing a minimally invasive insertion of saline, aqueous, or other fluid-fillable breast implants while preventing deflation and/or migration, as well as monitoring for leaks or leaks in implants (such as breast implants), pacemakers, implantable cardioverter-defibrillators, other unreliable devices, and other related devices ) . The device described in the application US2009254179 (Al) has the ability to be inserted in a minimal way invasive and to detect and communicate the appearance of loss of integrity in the casing of practically any implant. The device has a rupture sensor placed on the casing, which helps detect the status of the implant and if there is a leak, as well as any change in the physicochemical properties of the implant. A seal is placed over the rupture sensor to protect it.
El dispositivo de monitoreo de implantes propuesto en la solicitud US2009254179 (Al ) sirve como una solución a los problemas de : The implant monitoring device proposed in the application US2009254179 (Al) serves as a solution to the problems of:
1 ) Proporcionar una inserción mínimamente invasiva de implantes con rellenos de liquido salino o acuoso mientras se previene la deflación y/o migración; y, 1) Provide a minimally invasive insertion of implants with saline or aqueous fluid fillers while preventing deflation and/or migration; and,
2 ) Monitoreo de fugas o fugas en implantes ( como implantes mamarios , marcapasos , des f ibriladores automáticos implantables , otros dispositivos infiables y otros dispositivos relacionados ) . 2 ) Monitoring for leakage or leakage in implants ( such as breast implants , pacemakers , implantable cardioverter - defibrillators , other unreliable devices and other related devices ) .
3 ) Monitoreo continuo de la integridad del implante ; 3) Continuous monitoring of the integrity of the implant;
4 ) Señali zación de fallo de implante tanto para el paciente como para el profesional sanitario ; y, 4) Signaling of implant failure both for the patient and for the healthcare professional; and,
5 ) Capacidad de hacer que un sensor comunique , con un dispositivo externo , información sobre el estado de un dispositivo implantado . 5 ) Ability to make a sensor communicate , with an external device , information about the status of an implanted device .
El dispositivo para implantación mínimamente invasiva descrito en la solicitud US2009254179 (Al ) , está compuesto por una carcasa ; y un material de soporte dispuesto dentro de la carcasa, estando adaptado el material de soporte para ser comprimido para su implantación y posteriormente expandido ; donde dicho material de soporte comprende un hidrogel o material hidrófilo , el cual debe ser deshidratado antes de la implantación . El hidrogel deshidratado o el material hidrófilo es hiperosmótico de modo que se expande después de la implantación debido a la entrada de agua a través de la cubierta desde el tej ido circundante . La cubierta descrita en la solicitud US2009254179 (Al ) está configurada para ser un implante de mama, un implante pectoral , un implante de pantorrilla, un implante de biceps , un implante de glúteos , un implante de pene , un implante gástrico o un implante peritoneal ; y, dicha cubierta tiene una pluralidad de soportes de silicio forman una rej illa . The device for minimally invasive implantation described in the application US2009254179 (Al), is made up of a casing; and a support material disposed within the housing, the support material being adapted to be compressed for implantation and subsequently expanded; where said support material comprises a hydrogel or hydrophilic material, which must be dehydrated before implantation. the hydrogel dehydrated or hydrophilic material is hyperosmotic such that it expands after implantation due to ingress of water through the shell from surrounding tissue. The shell described in application US2009254179 (Al) is configured to be a breast implant, pectoral implant, calf implant, biceps implant, buttock implant, penile implant, gastric implant, or peritoneal implant. ; and, said cover has a plurality of silicon supports forming a grid.
También se encontró la solicitud de patente de Estados Unidos número US2008058926 (Al ) publicada el 06 de marzo de 2008 con titulo "MODI FICACIÓN PERCUTÁNEA DE MAMAS Y GLÚTEOS" el cual describe un aparato para la modi ficación de senos y glúteos que incluye un primer y un segundo tubos que se extienden uno al lado del otro , y cada uno de los cuales tiene una carcasa . El aparato también incluye un globo infiable que tiene una válvula que está acoplada de forma desmontable a un extremo distal del segundo tubo de manera que una parte del extremo distal se extiende a través de la válvula . El globo está adaptado para introducirse en un espacio de un cuerpo e inflarse en el espacio del cuerpo mediante un fluido introducido a través de la válvula a través del segundo tubo . Y el segundo tubo se separa del globo inflado para dej ar el globo inflado posicionado en el espacio del cuerpo . The United States patent application number US2008058926 (Al) published on March 6, 2008 with the title "PERCUTANEOUS MODIFICATION OF BREASTS AND GLUTEUS" was also found, which describes a device for the modification of breasts and buttocks that includes a first and a second tubes that extend one next to the other, and each of which has a casing. The apparatus also includes an inflatable balloon having a valve that is detachably attached to a distal end of the second tube such that a portion of the distal end extends through the valve. The balloon is adapted to be inserted into a body space and inflated in the body space by fluid introduced through the valve through the second tube. And the second tube is separated from the inflated balloon to leave the inflated balloon positioned in the body space.
El documento la solicitud US2008058926 (Al ) describe un implante infiable que tiene una válvula de autosellado que está acoplado de manera separable al extremo distal de uno de los tubos de manera que una parte del extremo distal del tubo se extiende a través de la válvula de autosellado . Se menciona que el segundo tubo se enrosca en el interior del globo en la posición de la válvula para asegurar el extremo distal del segundo tubo que se extiende a través de la válvula . The document application US2008058926 (Al) describes an unreliable implant having a self-sealing valve that is detachably coupled to the distal end of one of the tubes such that a portion of the distal end of the tube extends through the self-sealing valve. self sealing . It is mentioned that the second tube is threaded into the interior of the balloon in position of the valve to secure the distal end of the second tube that extends through the valve.
Otro documento encontrado es la solicitud de patente de Estados Unidos número US2015018945 (Al ) publicada el 15 de enero de 2015 con titulo "Prótesis de gravedad especi fica personali zable de pequeña incis ión" , dicha sol icitud se refiere a una prótesis personali zadle , por ej emplo una prótesis mamaria, que consta de una carcasa exterior de un material inerte biológicamente probado que encierra a los compartimentos de fluido y/o gas para formar una prótesis de características variadas . La prótesis contiene , al menos , un micro compartimento en una formación j erárquica en capas , cada uno de los cuales contiene un relleno que consiste en liquido , aire , gas , gel o una combinación de estos . La cantidad de relleno inyectada en cada micro compartimento varia según el tamaño y la forma que el individuo receptor busca lograr . Además , la naturaleza extraible de los micro compartimentos facilita la capacidad de personali zar la prótesis ( es decir, si se j usti fica una prótesis más pequeña, un médico puede extraer el relleno de la prótesis con un instrumento médico , o incluso quitar los micro compartimentos para cambiar la gravedad especi fica de la prótesis ) . Modi ficar el número de micro compartimentos y la cantidad de relleno en estos ayuda al individuo receptor a lograr un implante personali zado para sus necesidades especi ficas . Another document found is the United States patent application number US2015018945 (Al) published on January 15, 2015 with the title "Small incision customizable specific gravity prosthesis", said application refers to a personalized prosthesis, For example, a breast prosthesis, which consists of an outer casing of a biologically proven inert material that encloses the fluid and/or gas compartments to form a prosthesis of varied characteristics. The prosthesis contains at least one microcompartment in a hierarchical layered array, each of which contains a filler consisting of liquid, air, gas, gel, or a combination thereof. The amount of filler injected into each microcompartment varies according to the size and shape that the recipient individual seeks to achieve. In addition, the removable nature of the micro compartments facilitates the ability to customize the prosthesis (ie, if a smaller prosthesis is warranted, a clinician can remove the filler from the prosthesis with a medical instrument, or even remove the micros). compartments to change the specific gravity of the prosthesis). Modifying the number of microcompartments and the amount of filler in them helps the individual recipient to achieve an implant customized for their specific needs.
Además , el relleno inyectado puede comprender además un agente fluorescente que sirva como ayuda visual para los profesionales médicos cuando examinan el implante en la oscuridad baj o luz azul (por ej emplo , luz ultravioleta ) . El agente fluorescente crea un incentivo en la persona que lo recibe para reali zar un seguimiento periódico con su médico para los controles porque el médico examinador podrá determinar si el implante se ha desplazado del sitio del implante o si hay fugas presentes cuando se observa con luz azul . El agente fluorescente que se encuentra en el relleno facilita que un profesional médico examine la estructura de la prótesis en su conj unto con una minima invasividad . In addition, the injected filler may further comprise a fluorescent agent that serves as a visual aid to medical professionals when examining the implant in the dark under blue light (eg, ultraviolet light). The fluorescent agent creates an incentive in the person who you receive for regular follow-up with your doctor for checkups because the examining doctor will be able to tell if the implant has dislodged from the implant site or if leaks are present when viewed under blue light. The fluorescent agent in the filler makes it easy for a medical professional to examine the entire denture structure with minimal invasiveness.
La solicitud US2015018945 (Al ) reivindica una prótesis útil para implantar en tej ido blando que comprende : una capa exterior ; al menos un micro compartimento encapsulado por la carcasa exterior ; un tubo de llenado flexible ; y un puerto inyectable ; en el que la cubierta exterior de la prótesis comprende además un polímero con características estructurales dúctiles y similares a memoria ; en el que los micro compartimentos de la prótesis son extraibles y además están compuestos por un polímero con características estructurales dúctiles y similares a la memoria, en el que los micro compartimentos están dispuestos en un esquema de capas j erárquicas como un medio para reducir la gravedad especi fica total de la prótesis ; en el que el tubo de relleno flexible funciona como un medio para atravesar los rellenos de prótesis hasta los micro compartimentos ; y en el que el puerto inyectable funciona como un medio para modi ficar el volumen de los micro compartimentos . La prótesis comprende , además , al menos , un tubo de implante flexible y un puerto inyectable en el que , al menos , un micro compartimento extraible se extiende hacia fuera desde alli . La prótesis también cuenta con un medio para abrir y cerrar el puerto inyectable del tubo de implante ; asi como un tapón de polímero formulado para sellar el tubo de implante flexible . Otro documento encontrado fue el modelo de utilidad de China número CN2778230 (Y) , publicada el 10 de mayo de 2006 con el titulo "Cuerpo de falso relleno tipo inyección de caucho de silicona para glúteos" , dicha patente describe una prótesis de relleno falso de tipo inyección de goma de silicona para glúteos ; dicha prótesis se caracteri za porque el cuerpo de la bolsa de caucho de silicona es un cuerpo de bolsa cerrado y hueco en forma de disco circular o tapa es férica ; un tubo guia de caucho de silicona se fij a en la pared de la bolsa en el borde del cuerpo de la bolsa, y el extremo exterior del tubo guia está conectado con un cabezal de inyección en un modo de sellado . La prótesis descrita tiene las ventaj as de que el cuerpo de la bolsa se puede implantar en la nalga entre las dos nalgas después de enrollarlo en un cuerpo cilindrico y luego llenar con materiales de relleno , por lo que la dimensión de la muesca es pequeña y el dolor de los pacientes es pequeño ; permitiendo que los pacientes puedan recuperarse poco después de las operaciones . Application US2015018945 (Al) claims a prosthesis useful for implanting in soft tissue comprising: an outer layer; at least one micro compartment encapsulated by the outer casing; a flexible fill tube; and an injectable port ; wherein the outer shell of the prosthesis further comprises a polymer with ductile and memory-like structural characteristics; wherein the micro compartments of the prosthesis are removable and further comprised of a polymer with memory-like and ductile structural characteristics, wherein the micro compartments are arranged in a hierarchical layering scheme as a means of reducing gravity specific total of the prosthesis; wherein the flexible filler tube functions as a means to traverse the denture fillers into the micro compartments; and wherein the injectable port functions as a means to modify the volume of the microcompartments. The prosthesis further comprises at least one flexible implant tube and an injectable port in which at least one removable microcompartment extends outwardly therefrom. The prosthesis also has a means to open and close the injection port of the implant tube; as well as a polymer plug formulated to seal the flexible implant tube. Another document found was the Chinese utility model number CN2778230 (Y), published on May 10, 2006 under the title "Silicone Rubber Injection Type False Filler Body for Buttocks", said patent describes a false filler prosthesis of silicone rubber injection type for buttocks; Said prosthesis is characterized in that the body of the silicone rubber bag is a closed and hollow bag body in the shape of a circular disc or spherical lid; A silicone rubber guide tube is fixed to the bag wall at the edge of the bag body, and the outer end of the guide tube is connected with an injection head in a sealing mode. The described prosthesis has the advantages that the bag body can be implanted in the buttock between the two buttocks after being rolled into a cylindrical body and then filled with filling materials, whereby the dimension of the notch is small and the pain of the patients is small ; allowing patients to recover soon after operations.
Las fugas no son fáciles de producir después de las operaciones y el rendimiento de seguridad es bueno ; simultáneamente , el tubo guia también se puede encontrar desde la muesca en cualquier momento según sea necesario después de las operaciones , la altura de la nalga se puede aumentar o disminuir inyectando o extrayendo los materiales de relleno , o la prótesis se puede sacar completamente de la muesca original y limpiamente cuando no es necesario . Leakage is not easy to occur after operations, and the safety performance is good; Simultaneously, the guide tube can also be found from the notch at any time as needed after operations, the buttock height can be increased or decreased by injecting or removing the filler materials, or the prosthesis can be completely removed from the notch original and cleanly when not needed .
Por último se encontró una solicitud de patente de Estados Unidos de América número US20022091443 (Al ) , publicada el 11 de j ulio de 2002 con el titulo " IMPLANTE PROTÉS ICO PAPA AUMENTAR EL CUERPO, MÉTODOS DE AUMENTAR LA FORMA O APARIENCIA DE UN CUERPO Y UN INSTRUMENTO DE IMPLANTE PROTÉS ICO ENDOSCÓPICO" , dicha solicitud de patente describe un implante protésico para uso en el aumento de la forma de un cuerpo humano o reemplazo de tej ido corporal animal o humano , el cual incluye un miembro de cuerpo expansible que tiene una primera forma predeterminada y un primer volumen en una condición expandida y una segunda forma predeterminada en un segundo volumen más pequeño que el primer volumen en estado comprimido . Un instrumento de implante protésico endoscópico inserta el implante protésico a través de una pared anatómica de un cuerpo e incluye un miembro de manguito hueco , un miembro empuj ador y un mecanismo de tipo concha de almej a . Una combinación de endoscopio e instrumento de implante protésico incluye un endoscopio que tiene un canal de operación que recibe de manera desli zante el instrumento de implante protésico endoscópico . Un método que utili za el implante protésico aumenta la forma o apariencia de un cuerpo humano o el reemplazo de tej ido corporal animal o humano . Otro método usa el implante protésico j unto con el instrumento de implante protésico endoscópico para aumentar la forma o apariencia de un cuerpo humano o la sustitución de tej ido corporal o animal . Finally, a patent application from the United States of America number US20022091443 (Al) was found, published on July 11, 2002 with the title "ICO PROSTHETIC IMPLANT TO INCREASE THE BODY, METHODS OF INCREASING THE SHAPE OR APPEARANCE OF A BODY AND AN IMPLANT INSTRUMENT ENDOSCOPIC PROSTHETIC", said patent application describes a prosthetic implant for use in augmenting the shape of a human body or replacing animal or human body tissue, which includes an expandable body member having a first predetermined shape and a first volume in an expanded condition and a second predetermined shape in a second volume smaller than the first volume in a compressed state An endoscopic prosthetic implant instrument inserts the prosthetic implant through an anatomical wall of a body and includes a member of hollow sleeve, a pusher member, and a clam shell-type mechanism.A combination endoscope and prosthetic implant instrument includes an endoscope having an operating channel that slidably receives the endoscopic prosthetic implant instrument.A method that uses the prosthetic implant augments the shape or appearance of a human body or the replacement of body tissue animal or human oral. Another method uses the prosthetic implant in conjunction with the endoscopic prosthetic implant instrument to augment the shape or appearance of a human body or the replacement of body or animal tissue.
Como se puede observar, los documentos anteriormente descritos no describen que estén conformados por un instrumental con las características necesarias primero para introducir un trocar con un globo disector anatómico o redondo para separar los músculos de forma mínimamente invasiva y generar un espacio entre los músculos glúteos sin necesidad de cortarlos , segundo que permita inmediatamente después la colocación con ayuda del trocar con unos implantes redondos o anatómicos biperfilados o de doble perfil configurados para ser llenados in situ al tamaño deseado . Otra di ferencia entre el instrumental para colocar implantes rellenadles in situ de manera mínimamente invasiva motivo de la presente invención y los documentos descritos , es que ninguno describe una guia y un trocar que con el complemento de sus características evitan la fuga de aire cuando este se inyecte a un expansor que va a generar el espacio entre los músculos , asi como el material con el cual va a ser llenado el implante . As can be seen, the previously described documents do not describe that they are made up of instruments with the necessary characteristics first to introduce a trocar with an anatomical or round dissector balloon to separate the muscles in a minimally invasive way and create a space between the gluteal muscles without need to cut them, second that allows immediately after the placement with the help of the trocar with round or anatomical bi-profile or double-profile implants configured to be filled in situ to the desired size. Another difference between the instruments for placing implants that can be filled in situ in a minimally invasive manner that is the subject of the present invention and the documents described, is that none of them describes a guide and a trocar that, with the complement of their characteristics, prevent air leakage when it is applied. inject an expander that will generate the space between the muscles, as well as the material with which the implant will be filled.
Tampoco hay evidencia de un implante que imbrique de tal manera, que j unto con el mismo material con el que es lleno dicho implante y con la ayuda de un tapón con características especi ficas , se evita cualquier tipo de fugas que pueda tener . There is also no evidence of an implant that imbricates in such a way that, together with the same material with which said implant is filled and with the help of a cap with specific characteristics, any type of leakage it may have is avoided.
Los documentos citados anteriormente no evidencian contar con un instrumental que permita colocar un implante con una técnica mínimamente invasiva a través de incisiones pequeñas de 1 . 5cm, respetando el músculo glúteo el cual no será necesario incidir sino tan solo separar, con las ventaj as principales de disminución de las complicaciones , del dolor, recuperación rápida, reintegración rápida a sus labores y actividad física, entre otras , y por lo anterior un mej or resultado cosmético por el doble perfil que ofrece una mayor proyección del área glútea tanto en el implante redondo como en el anatómico . Por último , como se puede observar, ningún documento describe un implante biperfilado , fácil de acomodar y que no presente los problemas anteriormente descritos . OBJETO DE LA INVENCIÓN The documents cited above do not show that they have instruments that allow the placement of an implant with a minimally invasive technique through small incisions of 1 . 5cm, respecting the gluteus muscle, which will not need to be incised but only separated, with the main advantages of reducing complications, pain, rapid recovery, quick return to work and physical activity, among others, and for the above a better cosmetic result due to the double profile that offers a greater projection of the gluteal area in both the round and anatomical implants. Lastly, as can be seen, no document describes a bi-profile implant that is easy to accommodate and does not present the previously described problems. OBJECT OF THE INVENTION
Es , por lo tanto , obj eto de la presente invención, proporcionar un instrumental para colocar implantes rellenadles in situ de manera mínimamente invasiva , conformado por un trocar, un globo disector neumático biperfilado redondo y anatómico que permite reali zar en el primer paso un espacio entre los músculos sin necesidad de incidirlos , permitiendo inmediatamente después en el segundo paso se coloquen los implantes configurados para ser llenados in situ al tamaño deseado . It is, therefore, the object of the present invention, to provide an instrument for placing implants that can be filled in situ in a minimally invasive manner, made up of a trocar, a round and anatomical bi-profile pneumatic dissector balloon that allows a space to be made in the first step. between the muscles without the need to incise them, allowing immediately after in the second step to place the configured implants to be filled in situ to the desired size.
Otro obj eto de la presente invención es proporcionar un instrumental para colocar implantes rellenadles in situ de manera mínimamente invasiva que cuenta con un implante que es biperfilado redondo y anatómico configurado para ser llenados in situ al tamaño deseado , para posteriormente permitir que el largo del cuello de dicho implante se imbrique sobre su propio ej e hacia el interior del implante , para posteriormente introducir el tapón y evitar cualquier tipo de fugas . Another object of the present invention is to provide an instrument for placing implants that can be filled in situ in a minimally invasive manner that has an implant that is round and anatomical bi-profile configured to be filled in situ to the desired size, to subsequently allow the length of the neck to be adjusted. of said implant is imbricated on its own axis towards the interior of the implant, to later introduce the cap and avoid any type of leakage.
Otro obj eto de la presente invención es un instrumental para colocar implantes rellenadles in situ de manera mínimamente invasiva el cual permite que la colocación de dicho implante sea a través de incisiones pequeñas de 1 . 5cm, respetando el músculo glúteo el cual no será necesario incidir sino tan solo separarlo , con las ventaj as principales de disminución de las complicaciones , de dolor, recuperación rápida, reintegración rápida a sus labores y actividad física, entre otras , y por lo anterior un mej or resultado cosmético por el doble perfil que ofrece una mayor proyección del área glútea tanto en el implante redondo como en el anatómico . BREVE DESCRIPCIÓN DE LAS FIGURAS Another object of the present invention is a set of instruments for placing implants that can be filled in situ in a minimally invasive manner, which allows the placement of said implant to be through small incisions of 1. 5cm, respecting the gluteus muscle, which will not need to be incised but only separated, with the main advantages of reducing complications, pain, rapid recovery, rapid return to work and physical activity, among others, and for the above a better cosmetic result due to the double profile that offers a greater projection of the gluteal area in both the round and anatomical implants. BRIEF DESCRIPTION OF THE FIGURES
Los detalles característicos de este novedoso instrumental para colocar implantes rellenadles in situ de manera mínimamente invasiva se muestran claramente en la siguiente descripción y en las figuras que se acompañan, así como una ilustración de aquella, y siguiendo los mismos signos de referencia para indicar las partes mostradas . Sin embargo, dichas figuras se muestran a manera de ej emplo y no deben de ser consideradas como limitativas para la presente invención . The characteristic details of this innovative instrument for placing implants that can be filled in situ in a minimally invasive manner are clearly shown in the following description and in the accompanying figures, as well as an illustration thereof, and following the same reference signs to indicate the parts displayed . However, said figures are shown by way of example and should not be considered as limiting for the present invention.
La figura 1 muestra una vista en perspectiva del trocar del instrumental para colocar implantes rellenadles in situ de manera mínimamente invasiva . Figure 1 shows a perspective view of the instrument trocar for placing implants that can be filled in situ in a minimally invasive manner.
La figura 2 muestra una vista en perspectiva superior del tubo y la guía que conforman el trocar del instrumental para colocar implantes rellenadles in situ de manera mínimamente invasiva . Figure 2 shows a top perspective view of the tube and the guide that make up the trocar of the instruments for placing implants that can be filled in situ in a minimally invasive manner.
La figura 3 muestra una vista en perspectiva inferior del tubo y la guía que conforman el trocar del instrumental para colocar implantes rellenadles in situ de manera mínimamente invasiva . Figure 3 shows a bottom perspective view of the tube and the guide that make up the trocar of the instruments for placing implants that can be filled in situ in a minimally invasive manner.
La figura 4 muestra una vista en perspectiva de la guía y válvula del instrumental para colocar implantes rellenadles in situ de manera mínimamente invasiva . Figure 4 shows a perspective view of the guide and valve of the instruments for placing implants that can be filled in situ in a minimally invasive manner.
La figura 5 muestra una vista en perspectiva de la válvula de la guía del instrumental para colocar implantes rellenadles in situ de manera mínimamente invasiva . Figure 5 shows a perspective view of the instrument guide valve for placing implants that can be filled in situ in a minimally invasive manner.
La figura 6 muestra una vista a detalle de la válvula de la guía del instrumental para colocar implantes rellenadles in situ de manera mínimamente invasiva, donde se aprecia la membrana y protuberancias . Figure 6 shows a detailed view of the instrument guide valve for minimally filling implants in situ. invasive, where the membrane and protuberances can be seen.
La figura 7 muestra una vista frontal del implante del instrumental para colocar implantes rellenadles in situ de manera mínimamente invasiva . Figure 7 shows a front view of the implant of the instruments for placing implants that can be filled in situ in a minimally invasive manner.
La figura 8 muestra una vista en perspectiva del implante y tapón del instrumental para colocar implantes rellenadles in situ de manera mínimamente invasiva . Figure 8 shows a perspective view of the implant and cap of the instrumentation for placing implants that can be filled in situ in a minimally invasive manner.
La figura 9 muestra una vista en perspectiva de la transparencia del implante y tapón del instrumental para colocar implantes rellenadles in situ de manera mínimamente invasiva, donde el cuello del implante está imbricado . Figure 9 shows a perspective view of the transparency of the implant and cap of the instrument to place implants that can be filled in situ in a minimally invasive manner, where the neck of the implant is imbricated.
La figura 10 muestra una vista en perspectiva de la transparencia del implante y tapón del instrumental para colocar implantes rellenadles in situ de manera mínimamente invasiva, donde el cuello del implante está imbricado , donde se aprecia el ensamble entre los diafragmas y válvulas . Figure 10 shows a perspective view of the transparency of the implant and cap of the instrument to place filled implants in situ in a minimally invasive manner, where the neck of the implant is imbricated, where the assembly between the diaphragms and valves can be seen.
La figura 11 muestra una vista a detalle del ensamble de los diafragmas del tapón con las válvulas del cuello del implante del instrumental para colocar implantes rellenadles in situ de manera mínimamente invasiva . Figure 11 shows a detailed view of the assembly of the plug diaphragms with the implant neck valves of the instrumentation to place implants that can be filled in situ in a minimally invasive manner.
La figura 12 muestra una vista frontal del implante del instrumental para colocar implantes rellenadles in situ de manera mínimamente invasiva, con el tapón colocado . Figure 12 shows a front view of the implant of the instruments for placing implants that can be filled in situ in a minimally invasive manner, with the plug in place.
La figura 13 muestra una vista frontal del implante colocado sobre el trocar del instrumental para colocar implantes rellenadles in situ de manera mínimamente invasiva . La figura 14 muestra una vista frontal de la transparencia del globo disector colocado sobre el trocar del instrumental para colocar implantes rellenadles in situ de manera mínimamente invasiva . Figure 13 shows a front view of the implant placed over the trocar of the instrumentation to place implants that can be filled in situ in a minimally invasive manner. Figure 14 shows a front view of the transparency of the dissector balloon placed over the trocar of the instruments to place implants that can be filled in situ in a minimally invasive manner.
La figura 15 muestra una vista a detalle de la transparencia del globo disector colocado sobre el trocar del instrumental para colocar implantes rellenadles in situ de manera mínimamente invasiva . Figure 15 shows a detailed view of the transparency of the dissector balloon placed over the trocar of the instruments to place implants that can be filled in situ in a minimally invasive manner.
La figura 16 muestra una vista frontal de la transparencia del globo disector colocado sobre el trocar del instrumental para colocar implantes rellenadles in situ de manera mínimamente invasiva, donde se aprecia el globo disector, sin aire . Figure 16 shows a front view of the transparency of the dissector balloon placed over the trocar of the instruments to place implants that can be filled in situ in a minimally invasive manner, where the dissector balloon can be seen, without air.
La figura 17 muestra una vista frontal de la transparencia del globo disector colocado sobre el trocar del instrumental para colocar implantes rellenadles in situ de manera mínimamente invasiva, donde se aprecia la inyección de aire al globo disector . Figure 17 shows a front view of the transparency of the dissector balloon placed over the trocar of the instruments to place implants that can be filled in situ in a minimally invasive manner, where the injection of air into the dissector balloon can be seen.
La figura 18 muestra una diagrama de la generación de espacio en el músculo del glúteo por medio del globo disector del instrumental para colocar implantes rellenadles in situ de manera mínimamente invasiva . Figure 18 shows a diagram of the generation of space in the gluteal muscle by means of the dissector balloon of the instrumentation to place implants that can be filled in situ in a minimally invasive manner.
La figura 19 muestra una diagrama de la colocación y llenado con silicon del implante en el espacio generado en el músculo del glúteo por medio del globo disector del instrumental para colocar implantes rellenadles in situ de manera mínimamente invasiva . Figure 19 shows a diagram of the placement and filling with silicone of the implant in the space generated in the gluteus muscle by means of the dissector balloon of the instruments for placing implants that can be filled in situ in a minimally invasive manner.
La figura 20 muestra un diagrama de la posición preferente de las incisiones quirúrgicas al colocar implantes con el instrumental para colocar implantes rellenables in situ de manera mínimamente invasiva . Figure 20 shows a diagram of the preferred position of the surgical incisions when placing implants with the instrumentation to place minimally invasive in situ fillable implants.
DESCRIPCIÓN DETALLADA DE LA INVENCIÓN DETAILED DESCRIPTION OF THE INVENTION
Para una mej or comprensión de la invención, a continuación, se enlistan las partes que componen el instrumental para colocar implantes rellenables in situ de manera mínimamente invasiva : For a better understanding of the invention, the parts that make up the instruments for placing fillable implants in situ in a minimally invasive manner are listed below:
A. Trocar A. Trocar
B . Globo disector B. dissector balloon
C . Implante C. Implant
I . Tubo YO . Tube
2 . Guia 2 . Guide
3 . Válvula 3 . Valve
4 . Membrana 4 . Membrane
5 . Incisión 5 . Incision
6 . Protuberancias 6 . bumps
7 . Conector 7 . connector
8 . Perforaciones 8 . perforations
9 . Anillo de seguridad 9 . circlip
10 . Cuerpo de globo disector 10 . dissector balloon body
I I . Cuello de globo disector I I . dissector balloon neck
12 . Cuerpo de implante 12 . implant body
13 . Cuello de implante 13 . implant collar
14 . Válvula 14 . Valve
15 . Tapón fifteen . Plug
16 . Base 16 . Base
17 . Vástago 17 . Stem
18 . Diafragma Con referencia a las figuras, el instrumental para colocar implantes rellenadles in situ de manera mínimamente invasiva está conformado por, al menos, un trocar (A) que está compuesto por un tubo (1) graduado configurado para albergar una guia (2) que es de mayor longitud que dicho tubo y preferentemente es metálica. 18 . Diaphragm With reference to the figures, the instruments for placing implants that can be filled in situ in a minimally invasive manner are made up of at least one trocar (A) that is made up of a graduated tube (1) configured to house a guide (2) that is longer than said tube and is preferably metallic.
El tubo (1) graduado preferentemente es de un material transparente y en su extremo superior se coloca una válvula (3) de retención removible, la cual es un cilindro hueco de diámetro mayor al tubo (1) y con bordes romos; el extremo superior de dicha válvula (3) se encuentra tapado con una membrana (4) , el cual preferentemente es de silicon. The graduated tube (1) is preferably made of a transparent material and a removable check valve (3) is placed at its upper end, which is a hollow cylinder with a larger diameter than the tube (1) and with blunt edges; The upper end of said valve (3) is covered with a membrane (4), which is preferably made of silicone.
Tal como se muestra en las figuras 5 y 6, en el centro de la membrana (4) se coloca, al menos, una incisión (5) en forma de cruz dividiéndola en cuatro secciones que se encuentran unidas a la circunferencia de la válvula (3) , cada sección generada en la membrana (4) cuenta con, al menos, una protuberancias (6) las cuales permiten darle cuerpo a la membrana (4) para mantener su forma y darle hermetismo para evitar la fuga de cualquier fluido, el cual puede ser liquido o gaseoso. As shown in figures 5 and 6, in the center of the membrane (4) at least one incision (5) is placed in the shape of a cross, dividing it into four sections that are attached to the circumference of the valve ( 3), each section generated in the membrane (4) has at least one protrusions (6) which allow the membrane (4) to give body to maintain its shape and give it hermetic sealing to prevent the leakage of any fluid, the Which can be liquid or gas.
La guia (2) se introduce en el tubo (1) por su extremo superior, pasando a través de la incisión (5) en forma de cruz de la membrana (4) . La guia (2) es un tubo preferentemente metálico que tiene un conector (7) en su extremo superior y punta en su extremo inferior, la cual preferentemente es redondeada con bordes romos y cuenta con un orificio (8) que permite el paso de un fluido. El conector (7) es roscado de ajuste hermético tipo Luer-lock, configurado para conectar una cánula, jeringa, extensión o válvula de tres vias. La guia (2) cuenta con múltiples perforaciones (9) en el cuerpo cercanas al extremo inferior, lo que facilita la inyección de un fluido. The guide (2) is inserted into the tube (1) at its upper end, passing through the incision (5) in the shape of a cross in the membrane (4). The guide (2) is a preferably metallic tube that has a connector (7) at its upper end and a point at its lower end, which is preferably rounded with blunt edges and has a hole (8) that allows the passage of a fluent. The connector (7) is a threaded Luer-lock hermetic fit, configured to connect a cannula, syringe, extension or three-way valve. The guide (2) has multiple perforations (9) in the body near the lower end, which facilitates the injection of a fluid.
Al menos, una ranura (no ilustrada) se coloca en la circunferencia del cuerpo de la guia (2) , sobra la cual se coloca un anillo de seguridad (10) que permite un cierre hermético con la pared interna del tubo (1) , evitando junto con la membrana (4) la fuga de cualquier fluido. At least one slot (not illustrated) is placed on the circumference of the body of the guide (2), on which a safety ring (10) is placed that allows a hermetic seal with the internal wall of the tube (1), avoiding, together with the membrane (4), the leakage of any fluid.
Cuando la guia (2) se retira del interior del tubo (1) , las protuberancias (6) de la membrana (4) hacen que éste regrese a su forma natural uniendo la incisión (5) , de tal manera que sigue evitando que cualquier fluido tenga una fuga . When the guide (2) is withdrawn from inside the tube (1), the protuberances (6) of the membrane (4) make it return to its natural shape, joining the incision (5), in such a way that it continues to prevent any fluid is leaking.
Un globo disector (B) que preferentemente es de silicon, tiene un cuerpo (11) biperfilado el cuál puede ser anatómico o redondo, dicho cuerpo está unido a un cuello (12) el cual tiene una longitud de, al menos, la mitad del cuerpo (11) , de tal manera que la boca del cuello (no ilustrada) permita introducir el trocar (A) , para que el orificio (no ilustrado) de la punta del extremo inferior de la guia (2) asi como, al menos, una perforación (9) se encuentren dentro del cuerpo (11) , permitiendo introducir un fluido, que en el caso del globo disector (B) es aire. A dissector balloon (B), which is preferably made of silicone, has a bi-profile body (11) which can be anatomical or round. Said body is attached to a neck (12) which is at least half the length of the balloon. body (11), in such a way that the mouth of the neck (not illustrated) allows the introduction of the trocar (A), so that the hole (not illustrated) of the tip of the lower end of the guide (2) as well as, at least , a perforation (9) is inside the body (11), allowing a fluid to be introduced, which in the case of the dissector balloon (B) is air.
Tal como se aprecia en la figura 18, una vez que el globo disector (B) se encuentra posicionado sobre el trocar (A) , éste se puede asegurar por medio de un mecanismo de sujeción (no ilustrado) para asegurar su posición al momento de introducirlo entre el tejido muscular, que es el lugar donde se realizará el espacio para colocar el implante, posterior a la realización de una pequeña incisión quirúrgica de, al menos, un centímetro, longitud suficiente para introducir el trocar (A) con el globo disector (B) en el músculo donde se coloca el implante, para posteriormente introducir el aire en el globo disector (B) a través de la guia (2) permitiendo realizar un espacio en el músculo donde se colocará el implante sin necesidad de incidir, lo anterior se realiza de una manera rápida y fácil con minima invasión, disección adecuada, suficiente, respetando los planos anatómicos con la ventaja de disminuir las complicaciones que normalmente acompañan a este procedimiento cosmético al utilizar otro instrumental. Otra ventaja importante es que la inyección de aire al globo disector (B) da la oportunidad de elegir la forma y volumen adecuado para cada paciente al momento de realizar la intervención. As can be seen in figure 18, once the dissector balloon (B) is positioned on the trocar (A), it can be secured by means of a clamping mechanism (not illustrated) to ensure its position at the time of delivery. insert it between the muscle tissue, which is the place where the space will be made to place the implant, after making a small surgical incision of at least one centimeter, long enough to introduce the trocar (A) with the balloon dissector (B) in the muscle where the implant is placed, to later introduce air into the dissector balloon (B) through the guide (2) allowing a space to be made in the muscle where the implant will be placed without the need to incise, This is done quickly and easily with minimal invasion, adequate, sufficient dissection, respecting the anatomical planes with the advantage of reducing the complications that normally accompany this cosmetic procedure when using other instruments. Another important advantage is that the injection of air into the dissector balloon (B) gives the opportunity to choose the appropriate shape and volume for each patient at the time of the intervention.
Un implante (C) que preferentemente es de silicon, tiene un cuerpo (13) biperfilado el cuál puede ser anatómico o redondo, dicho cuerpo está unido a un cuello (14) el cual tiene una longitud de, al menos, la mitad del cuerpo (13) , de tal manera que la boca del cuello (no ilustrada) permita introducir el trocar (A) , y se asegura su posición por medio del mecanismo de sujeción (no ilustrado) ; el orificio (8) de la punta del extremo inferior de la guia (2) asi como, al menos, una perforación (9) se encuentren dentro del cuerpo (13) , permitiendo introducir un fluido, que en el caso del implante (C) es silicon grado médico u otro material biocompatible de más fácil inyección como ácido hialurónico por ejemplo. An implant (C) that is preferably made of silicone, has a bi-profile body (13) which can be anatomical or round, said body is attached to a neck (14) which has a length of at least half the body. (13), in such a way that the mouth of the neck (not illustrated) allows the introduction of the trocar (A), and its position is ensured by means of the clamping mechanism (not illustrated); The hole (8) at the tip of the lower end of the guide (2) as well as at least one perforation (9) are inside the body (13), allowing a fluid to be introduced, which in the case of the implant (C ) is medical grade silicone or another biocompatible material that is easier to inject, such as hyaluronic acid for example.
Tal como se aprecia en la figura 19, el implante (C) se posiciona en el espacio generado por el globo disector (B) , de tal manera que se respeta el músculo donde se coloca el implante, el cual no es necesario incidir sino tan solo separarlo, con las ventajas principales de disminución de dolor, recuperación rápida, reintegración rápida a sus labores y actividad fisica, entre otras, y por lo anterior un mejor resultado cosmético por el doble perfil que ofrece una mayor proyección del área donde es colocado el implante (C) ya sea en su forma redonda para aumentar solo glúteos, como en la anatómica para aumentar glúteo y cadera. La inyección del silicon será decidida de acuerdo con el volumen de aire que se inyectó al globo disector (B) . As can be seen in figure 19, the implant (C) is positioned in the space generated by the dissector balloon (B), in such a way that the muscle where the implant is placed is respected, which does not need to be incised but just as just separate it, with the main advantages of pain reduction, quick recovery, quick reintegration into their work and physical activity, among others, and therefore a better cosmetic result due to the double profile that offers a greater projection of the area where the implant is placed (C) either in its round shape to augment only the buttocks, or in the anatomical one. to increase gluteus and hip. The silicone injection will be decided according to the volume of air that was injected into the dissector balloon (B).
Con referencia a las figuras 7 a 12, la base del cuello (14) proximal al cuerpo (13) del implante (C) cuenta con, al menos, dos válvulas (15) , permitiendo que el cuello se imbrique sobre su propio eje hacia el interior del cuerpo (13) del implante (C) una vez que se llena de silicon, el cual con su propia presión interna del cuerpo (13) hace que el cuello se pegue a la pared interna de dicho cuerpo, evitando fugas. Un tapón (16) de silicon cuya base (17) tiene una forma anatómica y el vástago (18) tiene, al menos, dos diafragmas (19) que coinciden con el número de válvulas (15) , de tal manera que embonan entre si al introducir el tapón (16) en la boca del cuello (14) una vez que este se encuentra imbricado, generando un sello hermético que evita cualquier tipo de fuga del fluido que se encuentra al interior del cuerpo (13) del implante (C) . With reference to figures 7 to 12, the base of the neck (14) proximal to the body (13) of the implant (C) has at least two valves (15), allowing the neck to imbricate on its own axis towards the interior of the body (13) of the implant (C) once it is filled with silicone, which with its own internal pressure of the body (13) causes the neck to stick to the internal wall of said body, preventing leaks. A silicone plug (16) whose base (17) has an anatomical shape and the stem (18) has at least two diaphragms (19) that match the number of valves (15), in such a way that they fit together by inserting the plug (16) in the mouth of the neck (14) once it is imbricated, generating a hermetic seal that prevents any type of leakage of the fluid that is inside the body (13) of the implant (C) .
Para dar mayor seguridad a la prevención de fugas del fluido que se encuentra en el interior del cuerpo (13) del implante (C) , se puede utilizar un adhesivo no tóxico, preferentemente acrilico en el tapón (16) de tal manera que el ensamble de los diafragmas (19) con las válvulas (15) queda pegado mecánicamente. To give greater security to the prevention of leaks of the fluid that is inside the body (13) of the implant (C), a non-toxic adhesive, preferably acrylic, can be used in the stopper (16) in such a way that the assembly of the diaphragms (19) with the valves (15) is mechanically stuck.
La configuración de la longitud del cuello (14) del implante (C) , el número de válvulas (15) de dicho cuello junto con el número de diafragmas (19) que se encuentran en el vástago (18) del tapón (16) , permiten que la presión que se ejerce sobre el cuello (14) desde el interior del implante tener función de válvula para prevenir fugas. The configuration of the length of the neck (14) of the implant (C), the number of valves (15) of said neck together with the number of diaphragms (19) found in the stem (18) of the cap (16), allow the pressure exerted on the neck (14) from inside the implant to have a valve function to prevent leaks.
Los mecanismos de sujeción (no ilustrados) pueden ser anillos, ligas, cinchos, pegamento y/o la combinación de los anteriores. The fastening mechanisms (not illustrated) can be rings, rubber bands, straps, glue and/or a combination of the above.
REALIZACIÓN PREFERENTE DE LA INVENCIÓN PREFERRED EMBODIMENT OF THE INVENTION
Ejemplos examples
Los siguientes ejemplos ilustran una manera preferente, de cómo llevar a cabo la realización de la presente invención, por lo que no deben ser considerados como limitativos de la misma . The following examples illustrate a preferred way of how to carry out the implementation of the present invention, so they should not be considered as limiting the same.
Ejemplo 1. Colocación de implantes de glúteo por medio del instrumental para colocar implantes rellenadles in situ de manera mínimamente invasiva; en dos pasos. Example 1. Placement of gluteal implants by means of the instrumental for placing implants filled in situ in a minimally invasive way; in two steps.
Primer paso: tal como se aprecia en las figuras 18, 19 y 20, se realiza una incisión quirúrgica de 1 a 1.5 centímetros en el área superior de cada uno de los glúteos, para posteriormente separar el músculo glúteo externo de 0.5 a 1 centímetro e introducir en la incisión el trocar (A) con el globo disector (B) hasta que éste se encuentre bajo el músculo glúteo mayor; una vez ahi se inyecta aire a través de la guia (2) metálica hasta 700cc o más según sea el caso; una vez realizado el espacio o bolsillo por debajo del músculo glúteo, se retira el trocar (A) con el globo disector (B) ; éste último se puede retirar del trocar; y posteriormente, First step: as can be seen in figures 18, 19 and 20, a surgical incision of 1 to 1.5 centimeters is made in the upper area of each one of the buttocks, to later separate the external gluteus muscle from 0.5 to 1 centimeter and insert the trocar (A) with the dissector balloon (B) into the incision until it is under the gluteus maximus muscle; once there, air is injected through the metal guide (2) up to 700cc or more as the case may be; once the space or pocket below the gluteal muscle is made, the trocar (A) is removed with the dissector balloon (B); the latter can be removed from the trocar; and subsequently,
Segundo paso: colocar el implante (C) o se puede tener listo otro trocar (A) ya con el implante en posición, con la finalidad de que la cirugía se realice en el menor tiempo posible; se introduce el trocar (A) con el implante (C) hasta posicionarlo sobre el espacio generado; posteriormente se llena del silicon grado médico u otro material biocompatible; por medio de calor o con un pegamento y con la ayuda de una pinzas quirúrgicas se ejerce presión sobre el cuello (14) del implante (C) para imbricarlo al interior del cuerpo (13) del implante (C) después de retirar el trocar (A) , permitiendo que la presión generada por el silicon al interior del cuerpo (13) desplace el cuello a la pared interna de dicho cuerpo (13) , evitando fugas del silicon cuando el trocar (A) es retirado; posteriormente se coloca el tapón (16) sobre la boca del cuello (14) ; se ejerce presión sobre el tapón (16) para hacer que los diafragmas (19) de su vástago (18) se ensamblen con las válvulas (15) del cuello (14) del implante (C) , lo que genera un sello hermético y evita cualquier tipo de fuga del silicon; por último se realiza la sutura quirúrgica sobre cada incisión quirúrgica. Second step: place the implant (C) or another trocar (A) can be ready with the implant in position, so that the surgery can be performed as quickly as possible. possible time; the trocar (A) with the implant (C) is inserted until it is positioned over the space generated; later it is filled with medical grade silicone or other biocompatible material; by means of heat or with glue and with the help of surgical forceps, pressure is exerted on the neck (14) of the implant (C) to imbricate it inside the body (13) of the implant (C) after removing the trocar ( A), allowing the pressure generated by the silicone inside the body (13) to move the neck to the internal wall of said body (13), avoiding silicone leaks when the trocar (A) is removed; Subsequently, the plug (16) is placed on the mouth of the neck (14); pressure is exerted on the plug (16) to make the diaphragms (19) of its stem (18) assemble with the valves (15) of the neck (14) of the implant (C), which generates a hermetic seal and prevents any type of silicone leakage; finally, the surgical suture is performed over each surgical incision.
El invento ha sido descrito suficientemente como para que una persona con conocimientos medios en la materia pueda reproducir y obtener los resultados que mencionamos en la presente invención. Sin embargo, cualquier persona hábil en el campo de la técnica que compete el presente invento puede ser capaz de hacer modificaciones no descritas en la presente solicitud, sin embargo, si para la aplicación de estas modificaciones en una estructura determinada o en el proceso de manufactura de este, se requiere de la materia reclamada en las siguientes reivindicaciones, dichas estructuras deberán ser comprendidas dentro del alcance de la invención. The invention has been sufficiently described so that a person with average knowledge in the matter can reproduce and obtain the results that we mention in the present invention. However, any person skilled in the field of the technique that the present invention is competent may be able to make modifications not described in the present application, however, if for the application of these modifications in a determined structure or in the manufacturing process of this, the matter claimed in the following claims is required, said structures must be understood within the scope of the invention.

Claims

24 24
REIVINDICACIONES
1. Un instrumental para colocar implantes rellenables in situ de manera mínimamente invasiva, caracterizado porque comprende : i. Al menos, un trocar (A) conformado por un tubo (1) graduado configurado para albergar una guia (2) que es de mayor longitud que dicho tubo (1) ; ii. Un globo disector (B) que tiene un cuerpo (11) biperfilado que está unido a un cuello (12) ; por medio de la boca de dicho cuello (12) el globo disector (B) se coloca sobre el tubo (1) del trocar (A) ; y, iii. Un implante (C) que tiene un cuerpo (13) biperfilado unido a un cuello (14) ; por medio de la boca del cuello (14) el implante (C) se coloca sobre el tubo (1) del trocar (A) , una vez que es retirado el globo disector (B) . 1. A set of instruments for placing fillable implants in situ in a minimally invasive manner, characterized in that it comprises: i. At least one trocar (A) made up of a graduated tube (1) configured to house a guide (2) that is longer than said tube (1); ii. A dissector balloon (B) that has a bi-profile body (11) that is attached to a neck (12); through the mouth of said neck (12) the dissector balloon (B) is placed on the tube (1) of the trocar (A); and, iii. An implant (C) having a bi-profile body (13) attached to a neck (14); through the mouth of the neck (14) the implant (C) is placed on the tube (1) of the trocar (A), once the dissector balloon (B) is removed.
2. El instrumental de conformidad con la reivindicación anterior caracterizado porque, el tubo (1) graduado es de un material transparente y en su extremo superior se coloca una válvula (3) de retención. 2. The instrument in accordance with the preceding claim, characterized in that the graduated tube (1) is made of a transparent material and a check valve (3) is placed at its upper end.
3. El instrumental de conformidad con la reivindicación anterior caracterizado porque, la válvula (3) de retención es un cilindro hueco de diámetro mayor al tubo (1) y con bordes romos; y, el extremo superior de dicha válvula (3) se encuentra tapado con una membrana (4) , la cual tiene, al menos, una incisión (5) que divide en secciones unidas a la circunferencia de la válvula (3) , las cuales cuentan con, al menos, una protuberancias (6) . 3. The instrument in accordance with the preceding claim, characterized in that the check valve (3) is a hollow cylinder with a larger diameter than the tube (1) and with blunt edges; and, the upper end of said valve (3) is covered with a membrane (4), which has at least one incision (5) that divides into sections attached to the circumference of the valve (3), which They have at least one protuberance (6) .
4. El instrumental de conformidad con las reivindicaciones anteriores caracterizado porque, la válvula (3) de retención es removible. 4. The instrument in accordance with the preceding claims, characterized in that the check valve (3) is removable.
5. El instrumental de conformidad con las reivindicaciones 1 a 3 caracterizado porque, la membrana (4) es de silicon . 5. The instrument according to claims 1 to 3, characterized in that the membrane (4) is made of silicone.
6. El instrumental de conformidad con la reivindicación 3 caracterizado porque, la incisión (5) es en forma de cruz . 6. The instruments according to claim 3, characterized in that the incision (5) is cross-shaped.
7. El instrumental de conformidad con la reivindicación 1 caracterizado porque, la guia (2) es un tubo que tiene un conector (7) en su extremo superior y punta en su extremo inferior, dicha punta cuenta con un orificio (8) ; el cuerpo de la guia (2) cuenta con múltiples perforaciones (9) colocadas cercanas al extremo inferior; y, al menos, una ranura (no ilustrada) se coloca en la circunferencia del cuerpo de la guia (2) , sobra la cual se coloca un anillo de seguridad (10) . 7. The instrument according to claim 1, characterized in that the guide (2) is a tube that has a connector (7) at its upper end and a tip at its lower end, said tip has a hole (8); the body of the guide (2) has multiple perforations (9) placed close to the lower end; and, at least, one slot (not illustrated) is placed on the circumference of the body of the guide (2), on which a safety ring (10) is placed.
8. El instrumental de conformidad con las reivindicaciones 1 y 7 caracterizado porque, la punta de la guia (2) es redondeada con bordes romos. 8. The instrument according to claims 1 and 7, characterized in that the tip of the guide (2) is rounded with blunt edges.
9. El instrumental de conformidad con las reivindicaciones 1 y 7 caracterizado porque, el conector (7) es roscado de ajuste hermético tipo Luer-lock. 9. The instrument according to claims 1 and 7, characterized in that the connector (7) is threaded with a Luer-lock hermetic fit.
10. El instrumental de conformidad con la reivindicación 1 caracterizado porque, el cuerpo (11) biperfilado del globo disector (B) es anatómico o redondo. El instrumental de conformidad con las reivindicaciones 1 y 10 caracterizado porque, la longitud del cuello (12) es de, al menos, la mitad del cuerpo (11) . El instrumental de conformidad con las reivindicaciones 1, 10 y 11 caracterizado porque, el globo disector (B) es de silicon. El instrumental de conformidad con la reivindicación 1 caracterizado porque, el cuerpo (13) del implante (C) es anatómico o redondo. El instrumental de conformidad con las reivindicaciones 1 y 13 caracterizado porque, la longitud del cuello (14) es de, al menos, la mitad del cuerpo ( 13 ) . El instrumental de conformidad con las reivindicaciones 1, 13 y 14 caracterizado porque, el implante (C) es de silicon. El instrumental de conformidad con las reivindicaciones 1, 13, 14 y 15 caracterizado porque, el implante (C) se rellena con un fluido. El instrumental de conformidad con la reivindicación anterior, caracterizado porque el fluido un material biocompatible . El instrumental de conformidad con la reivindicación anterior, caracterizado porque el material biocompatible es silicon grado médico o ácido hialurónico. TI 10. The instrument according to claim 1, characterized in that the bi-profile body (11) of the dissector balloon (B) is anatomical or round. The instrument according to claims 1 and 10, characterized in that the length of the neck (12) is at least half the body (11). The instrument in accordance with claims 1, 10 and 11, characterized in that the dissector balloon (B) is made of silicone. The instruments according to claim 1, characterized in that the body (13) of the implant (C) is anatomical or round. The instrument according to claims 1 and 13, characterized in that the length of the neck (14) is at least half the body (13). The instruments according to claims 1, 13 and 14, characterized in that the implant (C) is made of silicone. The instrumental according to claims 1, 13, 14 and 15 characterized in that the implant (C) is filled with a fluid. The instruments in accordance with the preceding claim, characterized in that the fluid is a biocompatible material. The instruments according to the preceding claim, characterized in that the biocompatible material is medical grade silicone or hyaluronic acid. YOU
19. El instrumental de conformidad con las reivindicaciones 1 y 13 caracterizado porque, la base del cuello (14) proximal al cuerpo (13) del implante (C) cuenta con, al menos, dos válvulas (15) permitiendo que el cuello se imbrique sobre su propio eje hacia el interior del cuerpo (13) del implante (C) ; y, en la boca del cuello (14) imbricado se coloca un tapón (17) . 19. The instrument according to claims 1 and 13, characterized in that the base of the neck (14) proximal to the body (13) of the implant (C) has at least two valves (15) allowing the neck to overlap on its own axis towards the interior of the body (13) of the implant (C); and, in the mouth of the imbricated neck (14) a stopper (17) is placed.
20. El instrumental de conformidad con la reivindicación anterior, caracterizado porque el tapón (16) tiene una base (17) con forma anatómica y un vástago (18) , el cual tiene, al menos, dos diafragmas (19) que coinciden con el número de válvulas (15) del cuello (14) del implante (C) . 20. The instrument according to the preceding claim, characterized in that the stopper (16) has a base (17) with an anatomical shape and a stem (18), which has at least two diaphragms (19) that coincide with the number of valves (15) of the neck (14) of the implant (C).
21. El instrumental de conformidad con las reivindicaciones 1 y 13 caracterizado porque, un adhesivo no tóxico se coloca en el tapón (16) . 21. The instrument according to claims 1 and 13, characterized in that a non-toxic adhesive is placed on the stopper (16).
22. El instrumental de conformidad con la reivindicación anterior, caracterizado porque el adhesivo no tóxico es acrilico . 22. The instruments according to the preceding claim, characterized in that the non-toxic adhesive is acrylic.
23. El instrumental de conformidad con las reivindicaciones anteriores, caracterizado porque el globo disector (B) y el implante (C) se sujetan sobre el trocar (A) por medio de unos mecanismos de sujeción. 23. The instrument according to the previous claims, characterized in that the dissector balloon (B) and the implant (C) are held on the trocar (A) by means of clamping mechanisms.
24. El instrumental de conformidad con la reivindicación anterior, caracterizado porque los mecanismos de sujeción son anillos, ligas, cinchos, pegamento y/o la combinación de los anteriores. 24. The instruments according to the previous claim, characterized in that the fastening mechanisms are rings, garters, straps, glue and/or a combination of the above.
PCT/MX2022/050076 2021-09-13 2022-09-09 Instruments for minimally invasive insertion of implants that are fillable in situ WO2023038513A1 (en)

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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130226296A1 (en) * 2010-05-19 2013-08-29 Transmed7, Llc Methods and apparatus for in situ formation of surgical implants

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130226296A1 (en) * 2010-05-19 2013-08-29 Transmed7, Llc Methods and apparatus for in situ formation of surgical implants

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