WO2013059893A1 - Customised biopsy guide for ultra-sound transducers - Google Patents
Customised biopsy guide for ultra-sound transducers Download PDFInfo
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- WO2013059893A1 WO2013059893A1 PCT/BR2012/000375 BR2012000375W WO2013059893A1 WO 2013059893 A1 WO2013059893 A1 WO 2013059893A1 BR 2012000375 W BR2012000375 W BR 2012000375W WO 2013059893 A1 WO2013059893 A1 WO 2013059893A1
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- guide
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- customized guide
- cavity
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/08—Clinical applications
- A61B8/0833—Clinical applications involving detecting or locating foreign bodies or organic structures
- A61B8/0841—Clinical applications involving detecting or locating foreign bodies or organic structures for locating instruments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B10/0233—Pointed or sharp biopsy instruments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/34—Trocars; Puncturing needles
- A61B17/3403—Needle locating or guiding means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B10/0233—Pointed or sharp biopsy instruments
- A61B10/0241—Pointed or sharp biopsy instruments for prostate
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/34—Trocars; Puncturing needles
- A61B17/3403—Needle locating or guiding means
- A61B2017/3413—Needle locating or guiding means guided by ultrasound
Definitions
- the present Utility Model patent relates to a custom guide for medical imaging instruments. More specifically, the custom guide is coupled to different types of ultrasound transducer devices, provided they have geometry compatible with the guide coupling, to assist the clinician in viewing a specific part of the patient's body and can be used in biopsies. prostate, anesthesia, and aspiration in endocavitary procedures. When biopsy is required from a particular region of the prostate, a needle is inserted through the guide channel and then a portion of the desired tissue is withdrawn through the guide.
- the guide has a needle inlet nozzle that allows the urologist to spend less time inserting the biopsy needle into the device cavity, increasing the needle inlet area, and avoiding possible errors and unwanted punctures in the patient; a front extension to facilitate needle support before it is inserted through the cavity and inlet nozzle, making the procedure more practical.
- the proposed custom guide allows you to specifically speed up the biopsy procedure, reusability through the use of sterilizable material and better coupling of the device to the ultrasound.
- Biopsy is a simple procedure routinely performed by doctors. Specifically, the biopsy consists of removing a sample of cells and / or tissues from the living organism, in this case humans.
- the biopsy can be taken with the help of medical images like ultrasound. Medical imaging is used to correctly identify the area of interest for the sample to be taken from the right place. Some procedures may require the use of endoscopic probes, which are inserted into the body to generate an image, allowing the physician to clearly see where the biopsy should be performed.
- ultrasound the doctor follows the entire needle path in "real time" through the device monitor, always counting on the patient's collaboration. In this case, needle insertion should be performed as follows. accurate and fast, and the element that facilitates this procedure is the biopsy guide through which the needle is introduced into the patient. Different types of ultrasound transducers are used and for each use there is a need to use a biopsy guide appropriate to each transducer which has a particular geometry.
- US6368280-B1 refers to the device that most closely resembles the present utility model in that it has the same functionality but distinct utility.
- the object described in the US document has a very narrow needle inlet, which may lead to medical error, as the urologist may easily err in the device, causing injury to the patient.
- there is a kind of lateral slit along the device that allows external contamination not only of said device but also of the body cavity in which the device is found when performing tissue removal (biopsy).
- the guide proposed by the present model allows a secure coupling between the transducer and the needle, quick insertion and removal of the patient, thus increasing the efficiency and, consequently, shorter examination time, providing less discomfort to the patient.
- Improvement in the shape of the guide facilitates the physician's precision in introducing and removing the needle into the patient, enabling safer examinations without risk of patient injury, made of material suitable for sterilization and reuse.
- the present Utility Model patent is a custom guide to fit any type of transducer device. ultrasound, provided that the apparatus has a geometry similar to that of the proposed guide, both longitudinally and transversely.
- the custom guide is designed to address three main points related to its use: medical procedure time reduction; accuracy and agility in performing said procedure; and sterilization capacity of the material used.
- medical procedure time reduction For the purpose of reducing the time of the biopsy procedure, a kind of inlet nozzle was planned. This nozzle allows the urologist the doctor takes less time to insert the biopsy needle into the guide cavity, increasing the area for needle entry. In addition, the inlet nozzle avoids possible errors and unwanted punctures in the patient.
- a front extension has also been performed to facilitate needle support before it is inserted through the cavity and inlet nozzle, further reducing the risk of needle leakage and patient injury and making the procedure more practical and accurate.
- an inlet (5) configured to permit insertion of a needle (9) into the guide such as a biopsy needle comprising:
- a cavity (3) configured to allow the needle (9) to pass through and guide said needle (9) into the guide;
- an inlet nozzle (1) configured to allow accurate and rapid insertion of the needle (9) into the guide cavity (3) during the medical procedure, providing greater safety by preventing possible errors and unwanted punctures in the patient;
- a front extension (2) configured so that the needle can be supported and previously guided into the cavity, and allows the needle (9) to move longitudinally through the ultrasound transducer quickly and safely;
- a guide channel (6) configured to allow the needle (9) to travel inside the guide without the risk of escaping during the medical procedure;
- an outlet (7) configured to allow the needle to exit and direct the patient's cell tissue collection.
- a guide base (4) configured to allow the guide to be coupled to an ultrasonic transducer apparatus of suitable geometry; and e) a lock pin (8) configured to allow locking of the guide in the ultrasonic transducer apparatus.
- the custom guide can be coupled to different types of ultrasound transducer devices, provided they have geometry compatible with the guide coupling,
- the custom guide when coupled to an ultrasound transducer, assists the physician in viewing a specific part of the patient's body and can be used for prostate and transvaginal biopsies, anesthesia, and aspiration involving endocavitary procedures.
- a needle is inserted through the guide channel and then a portion of the desired tissue is withdrawn through the guide.
- the needle is preferably a standard biopsy needle and may be of different diameters, such as between 1 and 2 mm, preferably about 1 mm.
- the inlet (5) is preferably an opening that increases the area for the needle inlet.
- the cavity (3) extends from the front extension end (2) to the outlet end (7) having a length of between 125 and 140 mm, preferably 131 mm; and radius from 1 to 4 mm, preferably about 1 mm.
- the outer surface of the cavity (3) is of a polymer based material such as acrylonitrile butadiene styrene; polycarbonate; polyurethane; acrylate; polymethyl methacrylate; and epoxy, preferably acrylonitrile butadiene styrene; epoxy; and polymethylacrylate.
- a polymer based material such as acrylonitrile butadiene styrene; polycarbonate; polyurethane; acrylate; polymethyl methacrylate; and epoxy, preferably acrylonitrile butadiene styrene; epoxy; and polymethylacrylate.
- the inlet nozzle preferably comprises a semicircle shape which increases the area for positioning and insertion of the needle into the guide channel, wherein the radius of the half circle has a radius of between 3 and 9 mm, preferably about 5 mm.
- the inlet nozzle (1) may protrude over part of the front extension (2) forming a type of cover.
- - Front extension provides better safety and support to the needle before it is inserted through the cavity and inlet nozzle, further reducing the risk of the needle escaping the guide and injuring a patient, or even failure to collect the needle. cellular tissue, making the procedure more practical.
- the front extension (2) is between 2 and 10 mm in length, preferably about 6 mm.
- the guide channel (6) is preferably a rectangular part; elongated; arranged horizontally; and with the side edges slightly curved inwards.
- the guide base (4) may preferably be disposed horizontally and with the inwardly curved side ends forming a semi-arc where said side ends are flexible.
- the outlet (7) is preferably a hole with a diameter of about 2mm.
- the inlet (5); the guide channel (6); and outlet (7) preferably comprise a polymer-based one piece (such as acrylonitrile butadiene styrene, polycarbonate, polyurethane, acrylate, polymethyl methacrylate, and epoxy) capable of being sterilizable, either by ethylene oxide, autoclave, peracetic acid .
- a polymer-based one piece such as acrylonitrile butadiene styrene, polycarbonate, polyurethane, acrylate, polymethyl methacrylate, and epoxy
- Figure 1 Side view of the custom developed biopsy guide containing the main elements that compose it: inlet (1), front extension (2), cavity (3), guide base (4), inlet (5), guide channel (6) and outlet (7).
- Figure 2 Front view of the custom biopsy guide, highlighting the inlet nozzle (1), inlet (5), cavity (3), front extension (2), and guide base (4).
- Figure 3 Rear view of the custom biopsy guide highlighting the outlet (7), lock pin (8), and guide base (4).
- Figure 4 Rear view of the custom biopsy guide highlighting the dimensions of the guide base (4), especially the inwardly curved side ends forming a semi-arc where the radius of the semi-arc comprises about 7.5 mm.
- Figure 5 View of the proposed custom biopsy guide (A) coupled to a conventional ultrasound transducer apparatus (B), highlighting: inlet (5), guide base (6), outlet (7), and needle (9) .
- Figure 6 View of the custom biopsy guide highlighting its dimensions.
- This Utility Model refers to a custom guide to be fitted on ultrasound transducers that allows secure coupling between the ultrasound transducer and a needle, such as a biopsy needle, and quick insertion and withdrawal. patient, providing a reduction in the time of biopsy procedures and, consequently, less discomfort for patients; and the type of material to be manufactured is reusable through the use of sterilizable material.
- the device has an inlet nozzle (1) which allows the urologist to spend less time inserting the biopsy needle (9) into the guide cavity (3), increasing the needle inlet area and avoiding possible errors and punctures. unwanted in the patient; a front extension (2) to facilitate needle support before it is inserted through the recess (3) and inlet nozzle (1), further reducing more risks of the needle escaping the guide and injuring the patient, or even the failure to collect cell tissue, making the procedure more practical.
- the custom biopsy guide ( Figure 1) it is possible to observe its main components: inlet nozzle (1), front extension (2), cavity (3), guide base (4), inlet (5), guide channel (6), outlet (7), locking pin (8).
- the custom guide is preferably a one piece, which can be subdivided into input (5), guide channel (6) and output (7).
- the guide inlet (5) is where the biggest differentials of the device are, which has an inlet nozzle (1), preferably circular in shape, which increases the area for positioning and insertion of the needle (9) within guide channel (6), thus avoiding possible insertion errors in the guide channel (6).
- a "guide base” (4) so that needle (9) can be supported at the front (5) of the device before being inserted into the cavity (3) through the inlet nozzle. (1), providing greater firmness and stability during needle insertion (9).
- the needle (9) goes through the cavity to the outlet (7) of the guide which is fixed to the transducer via the lock pin (8).
- the needle (9) returns with the organic material to be biopsied, all contaminants remain within the cavity (3) of the custom biopsy guide.
- Figure 4 represents the proposed device coupled to a conventional ultrasound transducer for use in the medical field, especially for performing cancer biopsies.
- a biopsy needle 9
- the doctor locates the region to be biopsied, he inserts a biopsy needle (9) through the guide channel (6) of the device and removes the tissue to be analyzed more efficiently. Improvements made with the developed device allow the doctor to perform more daily appointments by reducing the length of the medical procedure.
- the agility in the biopsy procedure provided to the urologist in the cancer prevention scenario is due to the structure of the proposed device, which included a canal entry nozzle (1) and a guide base (4) for needle entry (9). ).
- a digitization of the coupling surface of the transducer apparatus provided the optimum custom coupling for said apparatus, allowing a perfect fit between the guide (A) and the transducer (B).
- the ultrasonic transducer devices in which the proposed custom guide can be coupled are all commercially used with geometric shape compatible with said custom guide, with the primary purpose of guiding the biopsy needles.
- the device when coupled to an ultrasonic transducer, allows the patient's prostate to be visualized, serving as a target for the removal of suspicious tissue.
- biopsy guides preferably for prostate cancer biopsies.
- These guides are coupled over the visualization system (B - Figure 5) of the prostate, which is nothing more than an ultrasound probe for anal insertion, and are extremely important for the urologist, as it is for this reason.
- the proposed guide has a key target role for the doctor to remove the portion he wants, optimizing the biopsy process.
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Abstract
Description
GUIA CUSTOMIZADA DE BIÓPSIA PARA APARELHOS TRANSDUTORES DE ULTRA-SOM CUSTOMIZED BIOPSY GUIDE FOR ULTRASOUND TRANSDUCER EQUIPMENT
Campo da invenção Field of the invention
A presente patente de Modelo de Utilidade refere-se a uma guia customizada para instrumentos de imagens médicas. Mais especificamente, a guia customizada é acoplada em diferentes tipos de aparelhos transdutores de ultra-som, desde que possuam geometria compatível com o acoplamento da guia, para auxiliar o médico na visualização de uma parte específica do corpo do paciente, podendo ser utilizada em biópsias prostáticas, anestesias, e aspiração em procedimentos endocavitários. Quando existe a necessidade de biópsia de determinada região da próstata, uma agulha é inserida através do canal da guia e então uma porção do tecido desejado é retirado através da guia. A guia possui um bocal de entrada da agulha que permite ao médico urologista despender menos tempo na inserção da agulha de biópsia na cavidade do dispositivo, aumentando a área de entrada da agulha, além de evitar possíveis erros e perfurações indesejadas no paciente; um prolongamento frontal para facilitar o apoio da agulha antes da mesma ser inserida através da cavidade e do bocal de entrada, tornando o procedimento mais prático. The present Utility Model patent relates to a custom guide for medical imaging instruments. More specifically, the custom guide is coupled to different types of ultrasound transducer devices, provided they have geometry compatible with the guide coupling, to assist the clinician in viewing a specific part of the patient's body and can be used in biopsies. prostate, anesthesia, and aspiration in endocavitary procedures. When biopsy is required from a particular region of the prostate, a needle is inserted through the guide channel and then a portion of the desired tissue is withdrawn through the guide. The guide has a needle inlet nozzle that allows the urologist to spend less time inserting the biopsy needle into the device cavity, increasing the needle inlet area, and avoiding possible errors and unwanted punctures in the patient; a front extension to facilitate needle support before it is inserted through the cavity and inlet nozzle, making the procedure more practical.
A guia customizada proposta permite agilizar, especificamente, o procedimento de biópsia, capacidade de reutilização através do uso de material esterilizável e melhor acoplamento do dispositivo no ultrassom. The proposed custom guide allows you to specifically speed up the biopsy procedure, reusability through the use of sterilizable material and better coupling of the device to the ultrasound.
Fundamentos da invenção Fundamentals of the invention
A biópsia é um procedimento simples realizado rotineiramente por médicos. Especificamente, a biópsia consiste na remoção de uma amostra de células e/ou tecidos do organismo vivo, no caso, seres humanos. A biópsia pode ser tomada com a ajuda de imagens médicas, como ultra-som. A imagem médica é usada para identificar corretamente a área de interesse para que a amostra seja colhida a partir do lugar certo. Alguns procedimentos podem exigir o uso de sondas endoscópicas, que são inseridos no corpo para gerar uma imagem, permitindo ao médico ver claramente o local em que deve ser feita a biópsia. No ultra-som, o médico acompanha todo o trajeto da agulha em "tempo real" pelo monitor do aparelho, sempre contando com a colaboração do paciente. Neste caso, a introdução da agulha deve ser realizada da forma mais precisa e rápida, e o elemento que facilita este procedimento é a guia de biopsia por onde a agulha é introduzida no paciente. Diferentes tipos de transdutores de ultra-som são utilizados e para cada uso tem-se a necessidade de utilizar uma guia de biopsia apropriada a cada transdutor, que possui uma geometria particular. Biopsy is a simple procedure routinely performed by doctors. Specifically, the biopsy consists of removing a sample of cells and / or tissues from the living organism, in this case humans. The biopsy can be taken with the help of medical images like ultrasound. Medical imaging is used to correctly identify the area of interest for the sample to be taken from the right place. Some procedures may require the use of endoscopic probes, which are inserted into the body to generate an image, allowing the physician to clearly see where the biopsy should be performed. In ultrasound, the doctor follows the entire needle path in "real time" through the device monitor, always counting on the patient's collaboration. In this case, needle insertion should be performed as follows. accurate and fast, and the element that facilitates this procedure is the biopsy guide through which the needle is introduced into the patient. Different types of ultrasound transducers are used and for each use there is a need to use a biopsy guide appropriate to each transducer which has a particular geometry.
Já é conhecido do estado da técnica o uso de guias acopladas em transdutores de ultrassom para auxiliar médicos nos procedimentos de biópsias, seja para ajudar na correta colocação da agulha ou catéter, seja para reduzir o tempo da biopsia. Contudo, algumas destas guias existentes no mercado funcionam somente com os transdutores originais e muitas delas não possuem a eficiência adequada no uso e no manuseio feito pelo médico. It is well known in the art to use guides coupled to ultrasound transducers to assist physicians in biopsy procedures, either to aid in correct needle or catheter placement or to reduce biopsy time. However, some of these guides on the market work only with original transducers and many of them do not have the proper efficiency in use and handling by the physician.
O documento US6368280-B1, por exemplo, refere-se ao dispositivo que mais se assemelha ao presente modelo de utilidade por apresentar a mesma funcionalidade, porém com utilidade distinta. O objeto descrito no documento americano possui uma entrada para a agulha muito estreita, o que pode induzir ao erro médico, uma vez que o médico urologista pode errar facilmente a entrada do dispositivo, causando lesões ao paciente. Além disso, existe uma espécie de fenda lateral ao longo do dispositivo que permite a contaminação exterior não só do dito dispositivo, mas também da cavidade do organismo em que o aparelho se encontra ao realizar a retirada de tecido (biópsia). US6368280-B1, for example, refers to the device that most closely resembles the present utility model in that it has the same functionality but distinct utility. The object described in the US document has a very narrow needle inlet, which may lead to medical error, as the urologist may easily err in the device, causing injury to the patient. In addition, there is a kind of lateral slit along the device that allows external contamination not only of said device but also of the body cavity in which the device is found when performing tissue removal (biopsy).
Desta forma, a guia proposta pelo presente modelo permite uma acoplagem segura entre o transdutor e a agulha, rápida inserção e retirada do paciente, havendo desta forma um ganho na eficência e, consequentemente, menor tempo de exame, proporcionando menor desconforto ao paciente, além de possibilitar seu uso customizado em diferentes transdutores de ultra-som, apresentando-se mais versátil quando comparado aos demais disponíveis no mercado. O aperfeiçoamento realizado na forma da guia facilita a precisão do médico na introdução e remoção da agulha no paciente, permitindo exames mais seguros sem riscos de lesão no paciente, fabricados em material adequado para esterilização e reuso. Thus, the guide proposed by the present model allows a secure coupling between the transducer and the needle, quick insertion and removal of the patient, thus increasing the efficiency and, consequently, shorter examination time, providing less discomfort to the patient. enable its custom use in different ultrasound transducers, being more versatile when compared to others available in the market. Improvement in the shape of the guide facilitates the physician's precision in introducing and removing the needle into the patient, enabling safer examinations without risk of patient injury, made of material suitable for sterilization and reuse.
Breve descrição da invenção Brief Description of the Invention
A presente patente de Modelo de Utilidade trata de uma guia customizada para ser adaptada em qualquer tipo de aparelho transdutor de ultra-som, desde que o dito aparelho possua uma geometria similar ao da guia proposta, tanto na direção longitudinal como na transversal. The present Utility Model patent is a custom guide to fit any type of transducer device. ultrasound, provided that the apparatus has a geometry similar to that of the proposed guide, both longitudinally and transversely.
A guia customizada foi projetada para solucionar três principais pontos relacionados ao seu uso: redução de tempo do procedimento médico; precisão e agilidade na realização do dito procedimento; e capacidade de esterilização do material utilizado. Para efeitos de redução no tempo do procedimento de biópsia, uma espécie de bocal de entrada foi planejada. Este bocal permite que o médico urologista despenda menos tempo para inserir a agulha de biopsia na cavidade da guia, aumentando a área para a entrada da agulha. Além disso, o bocal de entrada evita possíveis erros e perfurações indesejadas no paciente. Um prolongamento frontal também foi realizado para facilitar o apoio da agulha antes da mesma ser inserida através da cavidade e do bocal de entrada, reduzindo ainda mais os riscos de escapar a agulha e ferimentos no paciente, além de tornar o procedimento mais prático e preciso. The custom guide is designed to address three main points related to its use: medical procedure time reduction; accuracy and agility in performing said procedure; and sterilization capacity of the material used. For the purpose of reducing the time of the biopsy procedure, a kind of inlet nozzle was planned. This nozzle allows the urologist the doctor takes less time to insert the biopsy needle into the guide cavity, increasing the area for needle entry. In addition, the inlet nozzle avoids possible errors and unwanted punctures in the patient. A front extension has also been performed to facilitate needle support before it is inserted through the cavity and inlet nozzle, further reducing the risk of needle leakage and patient injury and making the procedure more practical and accurate.
É, portanto, objeto do presente Modelo uma guia customizada para ser adaptada em transdutores ultra-sônicos que compreende: It is therefore the object of this Model a custom guide to be adapted to ultrasonic transducers comprising:
a) uma entrada (5) configurada para permitir a inserção de uma agulha (9) na guia, tal como uma agulha de biópsia, compreendida por: a) an inlet (5) configured to permit insertion of a needle (9) into the guide such as a biopsy needle comprising:
- uma cavidade (3) configurada para permitir a passagem da agulha (9) e guiar a dita agulha (9) no interior da guia; - a cavity (3) configured to allow the needle (9) to pass through and guide said needle (9) into the guide;
- um bocal de entrada (1) configurado para permitir uma introdução precisa e rápida da agulha (9) na cavidade (3) da guia durante o procedimento médico, proporcionando maior segurança por evitar possíveis erros e perfurações indesejadas no paciente; - an inlet nozzle (1) configured to allow accurate and rapid insertion of the needle (9) into the guide cavity (3) during the medical procedure, providing greater safety by preventing possible errors and unwanted punctures in the patient;
- um prolongamento frontal (2), configurado para que a agulha possa ser apoiada e previamente guiada para o interior da cavidade, além de permitir que a agulha (9) percorra longitudinalmente o transdutor de ultra-som de forma rápida e segura; - a front extension (2), configured so that the needle can be supported and previously guided into the cavity, and allows the needle (9) to move longitudinally through the ultrasound transducer quickly and safely;
b) um canal guia (6) configurado para permitir que a agulha (9) percorra o interior da guia sem o risco de escapar durante o procedimento médico; c) uma saída (7) configurada para permitir a saída da agulha e direcionar a coleta de tecido celular do paciente. b) a guide channel (6) configured to allow the needle (9) to travel inside the guide without the risk of escaping during the medical procedure; c) an outlet (7) configured to allow the needle to exit and direct the patient's cell tissue collection.
d) uma base guia (4) configurada para permitir que a guia seja acoplada em um aparelho transdutor ultra-sônico de geometria adequada; e e) um pino-trava (8) configurado para permitir o travamento da guia no aparelho transdutor ultra-sônico. d) a guide base (4) configured to allow the guide to be coupled to an ultrasonic transducer apparatus of suitable geometry; and e) a lock pin (8) configured to allow locking of the guide in the ultrasonic transducer apparatus.
Onde: Where:
- a guia customizada pode ser acoplada em diferentes tipos de aparelhos transdutores de ultra-som, desde que possuam geometria compatível com o acoplamento da guia, - the custom guide can be coupled to different types of ultrasound transducer devices, provided they have geometry compatible with the guide coupling,
- a guia customizada, quando acoplada em um transdutor de ultra-som, auxilia o médico na visualização de uma parte específica do corpo do paciente, podendo ser utilizada em biópsias prostáticas e transvaginais, anestesias, e aspiração envolvendo procedimentos endocavitários. - The custom guide, when coupled to an ultrasound transducer, assists the physician in viewing a specific part of the patient's body and can be used for prostate and transvaginal biopsies, anesthesia, and aspiration involving endocavitary procedures.
- quando existe a necessidade de um procedimento de biópsia, tal como de uma biópsia de determinada região da próstata, uma agulha é inserida através do canal da guia e então uma porção do tecido desejado é retirado através da guia. When there is a need for a biopsy procedure, such as a biopsy from a particular region of the prostate, a needle is inserted through the guide channel and then a portion of the desired tissue is withdrawn through the guide.
- a agulha é preferencialmente uma agulha de biópsia padronizada, podendo ser de diferentes diâmetros, tal como entre 1 e 2 mm, preferencialmente cerca de 1 mm. The needle is preferably a standard biopsy needle and may be of different diameters, such as between 1 and 2 mm, preferably about 1 mm.
- a entrada (5) seja, preferencialmente, uma abertura que aumente a área para a entrada da agulha. - the inlet (5) is preferably an opening that increases the area for the needle inlet.
- a cavidade (3) se estende desde a extremidade do prolongamento frontal (2) até a extremidade da saída (7) tendo um comprimento compreendido entre 125 e 140 mm, preferencialmente 131 mm; e raio compreendido entre 1 e 4 mm, preferencialmente cerca de 1 mm. - the cavity (3) extends from the front extension end (2) to the outlet end (7) having a length of between 125 and 140 mm, preferably 131 mm; and radius from 1 to 4 mm, preferably about 1 mm.
- a superfície externa da cavidade (3) seja de um material a base de polímero, tais como acrilonitrila butadieno estireno; policarbonato; poliuretana; acrilato; polimetilmetacrilato; e epóxi, preferencialmente acrilonitrila butadieno estireno; epóxi; e polimetilacrilato. - the outer surface of the cavity (3) is of a polymer based material such as acrylonitrile butadiene styrene; polycarbonate; polyurethane; acrylate; polymethyl methacrylate; and epoxy, preferably acrylonitrile butadiene styrene; epoxy; and polymethylacrylate.
- o bocal de entrada compreende, preferencialmente, um formato de semicírculo, que aumenta a área para posicionamento e inserção da agulha dentro do canal guia, em que o raio do semi-círculo tenha um raio compreendido entre 3 e 9 mm, preferencialmente cerca de 5 mm. - o bocal de entrada (1) pode se projetar sobre parte do prolongamento frontal (2) formando um tipo de cobertura. - the inlet nozzle preferably comprises a semicircle shape which increases the area for positioning and insertion of the needle into the guide channel, wherein the radius of the half circle has a radius of between 3 and 9 mm, preferably about 5 mm. - the inlet nozzle (1) may protrude over part of the front extension (2) forming a type of cover.
- o prolongamento frontal permite uma melhor segurança e apoio à agulha, antes desta ser inserida através da cavidade e do bocal de entrada, reduzindo ainda mais os riscos de a agulha escapar da guia e ferir um paciente, ou até mesmo a falha na coleta do tecido celular, tornando o procedimento mais prático. - Front extension provides better safety and support to the needle before it is inserted through the cavity and inlet nozzle, further reducing the risk of the needle escaping the guide and injuring a patient, or even failure to collect the needle. cellular tissue, making the procedure more practical.
- o prolongamento frontal (2) tenha comprimento compreendido entre 2 e 10 mm, preferencialmente cerca de 6 mm. - the front extension (2) is between 2 and 10 mm in length, preferably about 6 mm.
- o canal guia (6) seja preferencialmente uma peça retangular; alongada; disposta horizontalmente; e com as extremidades laterais ligeiramente curvadas para dentro. - the guide channel (6) is preferably a rectangular part; elongated; arranged horizontally; and with the side edges slightly curved inwards.
- a base guia (4) possa estar, preferencialmente, disposta horizontalmente e com as extremidades laterais curvadas para dentro formando um semi-arco, onde as ditas extremidades laterais são flexíveis. - the guide base (4) may preferably be disposed horizontally and with the inwardly curved side ends forming a semi-arc where said side ends are flexible.
- a saída (7) seja, preferencialmente, um orifício com diâmetro de cerca de 2mm. - the outlet (7) is preferably a hole with a diameter of about 2mm.
- a entrada (5); o canal guia (6); e a saída (7) compreendem, preferencialmente, uma peça inteiriça a base de polímero (tais como acrilonitrila butadieno estireno, policarbonato, poliuretana, acrilato, polimetilmetacrilato, e epóxi) capaz de ser esterilizável, seja por óxido de etileno, autoclave, ácido peracetico. - the inlet (5); the guide channel (6); and outlet (7) preferably comprise a polymer-based one piece (such as acrylonitrile butadiene styrene, polycarbonate, polyurethane, acrylate, polymethyl methacrylate, and epoxy) capable of being sterilizable, either by ethylene oxide, autoclave, peracetic acid .
Os sinais de referência alfanuméricos mostrados entre parênteses apenas facilitam o entendimento da descrição da invenção, por isso não devem ser considerados como limitativos da extensão da matéria protegida pelas reivindicações. The alphanumeric reference signs shown in parentheses only make it easier to understand the description of the invention, and therefore should not be considered as limiting the extent of matter protected by the claims.
Breve descrição das figuras Brief Description of the Figures
Com finalidade meramente ilustrativa, e para facilitar a compreensão da presente patente de Modelo de Utilidade, as figuras descritas abaixo ilustram exemplos de concretização do dispositivo em questão sem, no entanto, restringi-lo. For illustrative purposes only, and to facilitate understanding of the present Utility Model patent, the figures described below illustrate examples of embodiment of the device in question without, however, restricting it.
Figura 1 - Vista lateral da guia customizada de biópsia desenvolvida contendo os principais elementos que a compõe: bocal de entrada (1), prolongamento frontal (2), cavidade (3), base guia (4), entrada (5), canal guia (6) e saída (7). Figure 1 - Side view of the custom developed biopsy guide containing the main elements that compose it: inlet (1), front extension (2), cavity (3), guide base (4), inlet (5), guide channel (6) and outlet (7).
Figura 2 - Vista frontal da guia customizada de biópsia, destacando o bocal de entrada (1), a entrada (5), a cavidade (3), o prolongamento frontal (2), e a base guia (4). Figure 2 - Front view of the custom biopsy guide, highlighting the inlet nozzle (1), inlet (5), cavity (3), front extension (2), and guide base (4).
Figura 3 - Vista traseira da guia customizada de biópsia destacando a saída (7), o pino-trava (8), e a base guia (4). Figure 3 - Rear view of the custom biopsy guide highlighting the outlet (7), lock pin (8), and guide base (4).
Figura 4 - Vista traseira da guia customizada de biópsia destacando as dimensões da base guia (4), especialmente as extremidades laterais curvadas para dentro que formam um semi-arco, onde o raio do semi- arco compreende cerca de 7,5 mm. Figure 4 - Rear view of the custom biopsy guide highlighting the dimensions of the guide base (4), especially the inwardly curved side ends forming a semi-arc where the radius of the semi-arc comprises about 7.5 mm.
Figura 5 - Vista da guia customizada de biópsia proposta (A) acoplada em um aparelho transdutor de ultra-som convencional (B), destacando: entrada (5), base guia (6), saída (7), e agulha (9). Figure 5 - View of the proposed custom biopsy guide (A) coupled to a conventional ultrasound transducer apparatus (B), highlighting: inlet (5), guide base (6), outlet (7), and needle (9) .
Figura 6 - Vista da guia customizada de biópsia com destaque as suas dimensões. Figure 6 - View of the custom biopsy guide highlighting its dimensions.
Descrição detalhada do Modelo Detailed Description of Model
A descrição ora apresentada ilustra uma das algumas formas de realizar o modelo de utilidade em questão. Por isso, não deve ser encarado de forma restritiva. The description presented here illustrates one of the ways to realize the utility model in question. Therefore, it should not be viewed restrictively.
O presente Modelo de Utilidade refere-se a uma guia customizada para ser adaptada em aparelhos transdutores de ultra-som que permite um acoplamento seguro entre o transdutor de ultra-som e uma agulha, tal como uma agulha de biópsia, e rápida inserção e retirada do paciente, proporcionando uma redução no tempo dos procedimentos de biópsia e, consequentemente, um menor desconforto aos pacientes; além de o tipo do material a ser fabricado possuir capacidade de reutilização através do uso de material esterilizável. This Utility Model refers to a custom guide to be fitted on ultrasound transducers that allows secure coupling between the ultrasound transducer and a needle, such as a biopsy needle, and quick insertion and withdrawal. patient, providing a reduction in the time of biopsy procedures and, consequently, less discomfort for patients; and the type of material to be manufactured is reusable through the use of sterilizable material.
O dispositivo possui um bocal de entrada (1) que permite ao médico urologista despender menos tempo na inserção da agulha (9) de biopsia na cavidade (3) da guia, aumentando a área de entrada da agulha, além de evitar possíveis erros e perfurações indesejadas no paciente; um prolongamento frontal (2) para facilitar o apoio da agulha antes da mesma ser inserida através da cavidade (3) e do bocal de entrada (1), reduzindo ainda mais os riscos de a agulha escapar da guia e ferir o paciente, ou até mesmo a falha na coleta do tecido celular, tornando o procedimento mais prático. The device has an inlet nozzle (1) which allows the urologist to spend less time inserting the biopsy needle (9) into the guide cavity (3), increasing the needle inlet area and avoiding possible errors and punctures. unwanted in the patient; a front extension (2) to facilitate needle support before it is inserted through the recess (3) and inlet nozzle (1), further reducing more risks of the needle escaping the guide and injuring the patient, or even the failure to collect cell tissue, making the procedure more practical.
Na representação esquemática da guia customizada de biopsia (Figura 1 ) é possível observar seus principais componentes que são: bocal de entrada (1), prolongamento frontal (2), cavidade (3), base guia (4), entrada (5), canal de guia (6), saída (7), pino-trava (8). A guia customizada é, preferencialmente, uma peça inteiriça, que pode ser subdividida em entrada (5), canal guia (6) e saída (7). Neste modelo, a entrada da guia (5) é onde se encontram os maiores diferenciais do dispositivo, a qual apresenta um bocal de entrada (1 ), preferencialmente em formato circular, que aumenta a área para posicionamento e inserção da agulha (9) dentro do canal de guia (6), evitando assim possíveis erros de inserção no canal de guia (6). Além disso, na entrada (5) do dispositivo se encontra uma "base guia" (4) para que agulha (9) possa ser apoiada na frente (5) do dispositivo antes de ser inserida na cavidade (3) através do bocal de entrada (1), proporcionando maior firmeza e estabilidade durante a inserção da agulha (9). Uma vez dentro do canal guia (6), o qual é fechado, a agulha (9) atravessa a cavidade até a saída (7) da guia que está fixada no transdutor através do pino-trava (8). Quando a agulha (9) retorna com o material orgânico a ser submetido à biópsia, todos os contaminantes permanecem no interior da cavidade (3) da guia customizada de biópsia. In the schematic representation of the custom biopsy guide (Figure 1) it is possible to observe its main components: inlet nozzle (1), front extension (2), cavity (3), guide base (4), inlet (5), guide channel (6), outlet (7), locking pin (8). The custom guide is preferably a one piece, which can be subdivided into input (5), guide channel (6) and output (7). In this embodiment, the guide inlet (5) is where the biggest differentials of the device are, which has an inlet nozzle (1), preferably circular in shape, which increases the area for positioning and insertion of the needle (9) within guide channel (6), thus avoiding possible insertion errors in the guide channel (6). In addition, at the inlet (5) of the device is a "guide base" (4) so that needle (9) can be supported at the front (5) of the device before being inserted into the cavity (3) through the inlet nozzle. (1), providing greater firmness and stability during needle insertion (9). Once inside the guide channel (6), which is closed, the needle (9) goes through the cavity to the outlet (7) of the guide which is fixed to the transducer via the lock pin (8). When the needle (9) returns with the organic material to be biopsied, all contaminants remain within the cavity (3) of the custom biopsy guide.
A Figura 4 representa o dispositivo proposto acoplado em um transdutor de ultra-som convencional para utilização na área médica, especialmente na realização de biópsias de câncer. Assim que médico localiza a região a ser biopsiada, o mesmo insere uma agulha de biópsia (9) através do canal guia (6) do dispositivo e retira o tecido a ser analisado com maior eficiência. As melhorias obtidas com o dispositivo desenvolvido possibilitam ao médico realizar uma quantidade maior de consultas diárias por proporcionar uma redução no tempo de procedimento médico. A agilidade no procedimento de biópsia proporcionada ao médico urologista no cenário de prevenção ao câncer se deve a estrutura do dispositivo proposto, onde foi incluído um bocal de entrada de canal (1) e uma base guia (4) para a entrada da agulha (9). Uma digitalização da superfície de acoplamento dos aparelhos transdutores forneceu o acoplamento ideal customizado para o dito aparelho, permitindo um encaixe perfeito entre a guia (A) e o transdutor (B). Os aparelhos transdutores ultra-sônicos em que a guia customizada proposta pode ser acoplada são todos aqueles utilizados comercialmente com forma geométrica compatível com a dita guia customizada, tendo como objetivo principal guiar as agulhas de biópsia. O dispositivo, quando acoplado a um transdutor ultra-sônico, permite a visualização da próstata do paciente, servindo de alvo para a retirada de tecido suspeito. Figure 4 represents the proposed device coupled to a conventional ultrasound transducer for use in the medical field, especially for performing cancer biopsies. As soon as the doctor locates the region to be biopsied, he inserts a biopsy needle (9) through the guide channel (6) of the device and removes the tissue to be analyzed more efficiently. Improvements made with the developed device allow the doctor to perform more daily appointments by reducing the length of the medical procedure. The agility in the biopsy procedure provided to the urologist in the cancer prevention scenario is due to the structure of the proposed device, which included a canal entry nozzle (1) and a guide base (4) for needle entry (9). ). A digitization of the coupling surface of the transducer apparatus provided the optimum custom coupling for said apparatus, allowing a perfect fit between the guide (A) and the transducer (B). The ultrasonic transducer devices in which the proposed custom guide can be coupled are all commercially used with geometric shape compatible with said custom guide, with the primary purpose of guiding the biopsy needles. The device, when coupled to an ultrasonic transducer, allows the patient's prostate to be visualized, serving as a target for the removal of suspicious tissue.
Tratam-se, portanto, de guias para biópsia, preferencialmente para biópsias de câncer de próstata. Estas guias (A - Figura 5) são acopladas sobre o sistema de visualização (B - Figura 5) da próstata, que nada mais é que uma sonda ultrassonica de inserção anal, e são de extrema importância para o médico urologista, pois é por esta guia (A - Figura 5) que é introduzida uma agulha (9) que irá retirar uma porção do tecido desejado, enquanto este é visualizado pelo aparelho de ultra-som (B - Figura 5). These are therefore biopsy guides, preferably for prostate cancer biopsies. These guides (A - Figure 5) are coupled over the visualization system (B - Figure 5) of the prostate, which is nothing more than an ultrasound probe for anal insertion, and are extremely important for the urologist, as it is for this reason. guide (A - Figure 5) that a needle (9) is inserted which will remove a portion of the desired tissue while it is viewed by the ultrasound device (B - Figure 5).
Desta forma, a guia proposta tem um papel fundamental de alvo para que o médico retire a porção que deseja, otimizando o processo de biópsia. Thus, the proposed guide has a key target role for the doctor to remove the portion he wants, optimizing the biopsy process.
Claims
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| BRMU9101886-2U BRMU9101886Y1 (en) | 2011-10-26 | 2011-10-26 | CUSTOMIZED BIOPSY GUIDE FOR ULTRASOUND TRANSDUCER APPARATUS |
| BRMU9101886-2 | 2011-10-26 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2013059893A1 true WO2013059893A1 (en) | 2013-05-02 |
Family
ID=48166963
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/BR2012/000375 Ceased WO2013059893A1 (en) | 2011-10-26 | 2012-09-20 | Customised biopsy guide for ultra-sound transducers |
Country Status (2)
| Country | Link |
|---|---|
| BR (1) | BRMU9101886Y1 (en) |
| WO (1) | WO2013059893A1 (en) |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4838506A (en) * | 1988-06-15 | 1989-06-13 | Cooper William I | Guidance device for ultrasound guided surgical procedures |
| US4877033A (en) * | 1988-05-04 | 1989-10-31 | Seitz Jr H Michael | Disposable needle guide and examination sheath for transvaginal ultrasound procedures |
| US6368280B1 (en) * | 1999-04-30 | 2002-04-09 | Civco Medical Instruments Inc. | Endocavity needle guide apparatus and method |
| US20060200042A1 (en) * | 2005-03-04 | 2006-09-07 | Ethicon Endo-Surgery, Inc. | Biopsy device incorporating an adjustable probe sleeve |
-
2011
- 2011-10-26 BR BRMU9101886-2U patent/BRMU9101886Y1/en active IP Right Grant
-
2012
- 2012-09-20 WO PCT/BR2012/000375 patent/WO2013059893A1/en not_active Ceased
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4877033A (en) * | 1988-05-04 | 1989-10-31 | Seitz Jr H Michael | Disposable needle guide and examination sheath for transvaginal ultrasound procedures |
| US4838506A (en) * | 1988-06-15 | 1989-06-13 | Cooper William I | Guidance device for ultrasound guided surgical procedures |
| US6368280B1 (en) * | 1999-04-30 | 2002-04-09 | Civco Medical Instruments Inc. | Endocavity needle guide apparatus and method |
| US20060200042A1 (en) * | 2005-03-04 | 2006-09-07 | Ethicon Endo-Surgery, Inc. | Biopsy device incorporating an adjustable probe sleeve |
Also Published As
| Publication number | Publication date |
|---|---|
| BRMU9101886U2 (en) | 2013-09-03 |
| BRMU9101886Y1 (en) | 2019-08-06 |
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